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.
Incorrect version of instructions for use (ifu) for the xylocaine product that is supplied with the cranial kits.
Acción
Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
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.
Incorrect version of instructions for use (ifu) for the xylocaine product that is supplied with the cranial kits.
Acción
Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
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
Massager, vacuum, radio frequency induced heat - Product Code OPT
Causa
Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
Acción
Cutera sent an IMPORTANT SAFETY INFORMATION letter dated October 16, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
It is important that you share this correspondence and the updated Operator Manual andvtreatment guidelines with all staff at your office that use the truSculpt, so they are aware of this new safety information. Please immediately remove and dispose of the current truSculpt Operator Manual and clinical guidelines and replace them with the new and revised truSculpt Operator Manual and clinical guidelines.
Customers with questions were instructed to call 415-657-5500 or 415-657-5568.
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
tissue adhesive for use in embolization of brain arteriovenous malformations - Product Code KGG
Causa
Incorrect instructions for use (ifu).
Acción
The firm, CODMAN Neuro, sent a "Medical Device Correction Notice" letter dated October 21, 2013 to its consignees/customers. The letter describes the product, problem and actions taken. The letter informed the consignees/customers of the incorrect statement in the IFU. The Corrected IFU was provided. Codman Neuro is in the process of updating the Instructions for Use to include the corrected information. Consignees/customers were instructed to complete and return the Correction Notice Acknowledgement Form and fax it to Codman Neuro at 508-977-6665.
For additional information, please contact Codman Neuro representative at 1-866-491-0974.
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
tissue adhesive for use in embolization of brain arteriovenous malformations - Product Code KGG
Causa
Incorrect instructions for use (ifu).
Acción
The firm, CODMAN Neuro, sent a "Medical Device Correction Notice" letter dated October 21, 2013 to its consignees/customers. The letter describes the product, problem and actions taken. The letter informed the consignees/customers of the incorrect statement in the IFU. The Corrected IFU was provided. Codman Neuro is in the process of updating the Instructions for Use to include the corrected information. Consignees/customers were instructed to complete and return the Correction Notice Acknowledgement Form and fax it to Codman Neuro at 508-977-6665.
For additional information, please contact Codman Neuro representative at 1-866-491-0974.
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
Electrode, Depth - Product Code GZL
Causa
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the vii cranial nerve. .
Acción
Consignees were sent on 10/8/2014 an AD-TECH "Medical Device Recall" letter dated October 6, 2014. The letter described the Reason for the Voluntary Recall, Risk to Health, Action to be taken by the Customer, Product and Distribution Information and Other Information. Requested consignees to return the "Acknowledgement and Receipt Form" to their Ad-Tech Clinical Specialists Fax 262-634-5668, Telephone 262-634-1555, customersupport@adtechmedical.com. For additional information they can use the same number.
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.
Certain model ns-p probes contained in the neurosensor cerebral blood flow and intracranial pressure monitoring kit may allow an intracranial pressure (icp) drift of up to ¿ 5 mmhg during the first 24 hours of monitoring icp. this is outside the products labeling specification of ¿ 2 mmhg maximum icp drift within the first 24 hours of monitoring.
Acción
Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product.
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
Neurological Tray - Product Code OJG
Causa
Significant compromised sterility, not limited to potentially damaged packaging. serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Acción
Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.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.
Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Letters request that users take the following actions:
1. Immediately locate the subject devices and quarantine them.
2. Distribute this notice to all affected Departments in your facility.
3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations.
a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately.
4. Complete and sign the attached Customer Response Form and:
a. Fax it to: 1-866-876-4355 or
b. E-mail a copy to: NeuroComplaints@stryker.com
c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices.
5. Keep a copy of the completed, signed Customer Response Form for your
records.
Stryker Customer Service reps will contact customers to arrange for replacement.
Any returned product will be quarantined and destroyed.
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.
Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Letters request that users take the following actions:
1. Immediately locate the subject devices and quarantine them.
2. Distribute this notice to all affected Departments in your facility.
3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations.
a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately.
4. Complete and sign the attached Customer Response Form and:
a. Fax it to: 1-866-876-4355 or
b. E-mail a copy to: NeuroComplaints@stryker.com
c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices.
5. Keep a copy of the completed, signed Customer Response Form for your
records.
Stryker Customer Service reps will contact customers to arrange for replacement.
Any returned product will be quarantined and destroyed.
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.
Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Letters request that users take the following actions:
1. Immediately locate the subject devices and quarantine them.
2. Distribute this notice to all affected Departments in your facility.
3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations.
a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately.
4. Complete and sign the attached Customer Response Form and:
a. Fax it to: 1-866-876-4355 or
b. E-mail a copy to: NeuroComplaints@stryker.com
c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices.
5. Keep a copy of the completed, signed Customer Response Form for your
records.
Stryker Customer Service reps will contact customers to arrange for replacement.
Any returned product will be quarantined and destroyed.
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
intracranial neurovascular stent - Product Code NJE
Causa
Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Letters request that users take the following actions:
1. Immediately locate the subject devices and quarantine them.
2. Distribute this notice to all affected Departments in your facility.
3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations.
a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately.
4. Complete and sign the attached Customer Response Form and:
a. Fax it to: 1-866-876-4355 or
b. E-mail a copy to: NeuroComplaints@stryker.com
c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices.
5. Keep a copy of the completed, signed Customer Response Form for your
records.
Stryker Customer Service reps will contact customers to arrange for replacement.
Any returned product will be quarantined and destroyed.
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 reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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 reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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 reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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 reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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 reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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
Tong, skull for traction - Product Code HAX
Causa
The reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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
Tong, skull for traction - Product Code HAX
Causa
The reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
Acción
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
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
Intracranial aneurysm flow diverter - Product Code OUT
Causa
The firm is recalling pipeline and pipeline flex embolization devices from u.S. since the devices were shipped with an eu version of the instructions for use.
Acción
The firm, Medtronic, sent a "Notification of Recall" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken.
The firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product.
The firm asks customers to take the following steps:
1) Stop using this product immediately.
2) Segregate this product from other Inventory.
3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. Customer Service will issue an RGA number for the return of the affected product back to Medtronic Neurovascular.
4) Upon receipt of an RGA number, write the RGA number on the FEDEX
slip and send the product back to: Medtronic Neurovascular, Attention: Product Recall, 9775 Toledo Way, Irvine, CA 92618. Prepaid and preaddressed FEDEX slips are enclosed for convenience.
5. Once they receive the returned units, product replacement units will be shipped directly to customers. The local Neurovascular representative can also be available to assist in expediting the exchange of product.
For any questions contact directly at 949-680-1340.
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
Motor, drill, pneumatic - Product Code HBB
Causa
The wire pass hole is not present on the tools.
Acción
A recall letter was mailed to consignees on October 21, 2015.
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
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Causa
Medtronic has identified an increased number of complaints from customers involving reports of rechargers (medtronic model 37751 recharger, which is included in models 37754 and 97754 charging systems,spinal cord stimulation)that are in an unresponsive error state, where the recharger is non-functional with a blank display screen and is beeping every 5 seconds. medtronic has determined all rechargers manufactured starting in november 2014 (indicated by serial numbers beginning with nka4 or nku4 ) are more susceptible to this error state.
Acción
Consignees were sent a series of documents which included an introductory Medtronic and "Urgent Medical Device Correction" letters dated September 2016. The urgent letters included one for Deep Brain Stimulation (DBS) and one for Spinal Cord Stimulation(SCS) . Each letter was addressed to Healthcare Professional. Only physicians associated with both SCS and DBS therapy received the cover letter.
The letters provided information on "Background, Issues Mitigation, Recommendation, Additional Information and Patient Notification (DBS).
Requested consignees to complete and return the Physician /HCP Reply Form.
For questions contact Medtronic Technical Services at 1-800-707-0933 weekdays 7 am to 6pm, CT.
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.
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the algovita spinal cord stimulation system.
it has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Acción
Nuvectra field sales associate or contracted distributor were sent a Nuvectra Urgent Field Safety Notice (Field Action Number: 2016-03) on 10/11/2016 via Fed-Ex. The letter provided background information, described the problem, & the product involved in the recall. The letter listed the potential clinical implications, rate of occurrence, recommendations and mitigations and action needed. Provided consignees with notices for them to deliver to physicians as well as Response forms for them and the physician. For questions contact Kathy Jo Fahery +01.763.951.8219.
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
Motor, drill, electric - Product Code HBC
Causa
Supplied directions for use (dfu) did not contain a recommended service interval.
Acción
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.
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.
Supplied directions for use (dfu) did not contain a recommended service interval.
Acción
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.