U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
Acción
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.
Customers were instructed to contact their local Sales Representative for any questions.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected lots of stromatolyser-im lysing reagent was found to be contaminated with pseudomonas bacteria, which resulted in rising imi channel background counts, increased false "platelet clump" flags and a strong sulfur-like odor when used on the xe-2100, xe-2100l and xe-5000 analyzers.
Acción
Sysmex America, Inc. sent a "MEDICAL DEVICE RECALL" letter dated June 2009 to all affected customers. The letter identifies the product, problem, and actions to be taken.
The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax at 800-218-2711. The form will be used to place orders to replace the affected product.
Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There a potential patient safety issue when using the symbia radiation therapy pallet. when a patient is not iso-centered before starting a scan with the symbia t series systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.
Acción
Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated June 06, 2011 to all affected customers.
The letter informs customers of the potential safety issue if the patient is not iso-centered before starting a scan and a non-circular orbit is selected and provided recommendations including ensure the patient is iso-centered before starting a scan. If the patient cannot be positioned at the iso-center of the RTP, instructions were provided. The customers are asked to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
For questions or assistance contact Siemens Medical Solutions USA, Inc. at (800) 888-7436 (USA).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Pet shrink sleeve insulation material dislodging
from the distal tips of autonomy laparo-angle (ala) metzenbaum scissors.
Acción
Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced.
Questions regarding this recall, call 508-405-0790 for assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Pet shrink sleeve insulation material dislodging
from the distal tips of autonomy laparo-angle (ala) metzenbaum scissors.
Acción
Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced.
Questions regarding this recall, call 508-405-0790 for assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Restoration, base metal - Product Code NSQ
Causa
Biomet 3i of palm beach gardens, fl is recalling their certain ep healing abutment (iwth56). the healing abutment dimensions did not match outside label and laser etching on part. the product was actually 8mm but the package indicated 6mm.
Acción
The firm, BIOMET 3i, initially contacted each US customer by telephone using a prepared phone script. Following telephone contact, the firm followed up each call with a faxed "Urgent: Medical Device Recall" letter dated March 1, 2010. International customers were notified first by email then by fax. The letter and email described the product, problem and actions to be taken. The customers were instructed to return the healing abutment(s) for replacement if they have not already opened and used the product; respond with the attached response fax and return the product(s) to the: Regulatory Affairs Department, BIOMET 3i, 4555 Riverside Drive, Palm Beach Gardens, FL 33410, Incident No. IC95863. BIOMET will send a replacement healing abutment(s) once the returned product is received.
If you have any questions or concerns, please contact the Recall Coordinator at 561-776-6906.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Biomet microfixation, jacksonville, fl is recalling center drive blade, 2.0, model number 01-9047, lot # 064980. product is non-conforming (blades do not retain screws).
Acción
The firm, Biomet Microfixation, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed.
If you have any questions, contact the Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. expanded: boston scientific is initiating a recall of all icross coronary imaging catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.
Acción
Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications.
The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation.
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Definitive Castable Cylinder for Dental Restoration - Product Code NHA
Causa
Biomet 3i, palm beach gardens, fl is recalling the model lpccc2 low profile abutment, non-hexed castable cylinder, lots 2010101036 and 2010101037 exp. 10/2015. package labeling may not correctly describe the package contents. product was distributed in europe only.
Acción
Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers.
The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification.
For additional information, please contact Customer Service at 800-342-5454.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
On 12/14/2010, smith & nephew, inc. wound management division in st. petersburg, fl recalled their renasys port product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
Acción
Smith & Nephew, Inc., Wound Management sent an URGENT DEVICE RECALL letter dated December 14, 2010, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to immediately identify and isolate the recalled lots in their inventory, complete and fax the response form, and return any affected products to APL Logistics, Inc. in Suwanee, GA. For questions in general, please contact the Customer Care Center at 1-800-876-1261.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Causa
Conmed linvatec, largo, fl is recalling crossft suture anchor with two #2 hi-fi sutures, lot 211581, product number cfp-5502. there is a possibility that the product may have been incorrectly assembled. the disposable driver may have the incorrect color handle (red versus black).
Acción
ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product.
Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions.
*****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers.
The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radiation Treatment Planning System - Product Code MUJ
Causa
In affected eclipse versions, user editing of the mlc leaf positions may not automatically invalidate calculated dose distributions.
Acción
Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers.
***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future.
For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Linear Accelerator for Radiation Therapy System - Product Code IYE
Causa
Some drive stand bolts may fail to meet mechanical specifications.
Acción
Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers.
The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary.
For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Cardiovascular Thermal Regulating System - Product Code DWJ
Causa
The probe jack contacts (terminals) on certain of the firm's ecmo heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. if this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
Acción
Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers.
The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form.
For additional contact the firm at 1-800-989-7373 or (513) 772-8810.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Cardiovascular Thermal Regulating System - Product Code DWJ
Causa
The probe jack contacts (terminals) on certain of the firm's ecmo heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. if this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
Acción
Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers.
The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form.
For additional contact the firm at 1-800-989-7373 or (513) 772-8810.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
An issue has been detected when using the rt chart function in aria versions 8.0 and 8.1. when users select the "convert to setup field" option, a set-up field is created, that removes the dmlc plan components in order to create an open collimator field for setup purposes.
Acción
Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.
***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***