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.
Complaints of malfunction of the halo ultra ablation catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.
Acción
BARRX Medical, Inc. sent a "PRODUCT RECALL NOTIFICATION" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. B¿RRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The "Steps for Voluntary Recall" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to B¿RRX Medical Customer Service at 888-662-2779.
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.
An additional air detection system is being added to all existing systems to detect air in the system's return line.
Acción
CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers.
Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months.
Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.
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.
Notas adicionales en la data
System, communication, powered - Product Code ILQ
Causa
Lithium batteries may overheat and become combustible.
Acción
Tobii Technology AB sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
Customers were advised to stop using the batteries and to remove them from their devices. They were instructed to dispose of the batteries in an environmentally responsible manner as hazardous materials. Tobii will replace the affected batteries. Customers were asked to complete and return an acknowledgement form via fax at 781-461-8213 or e-mail at recall@tobiiati.com.
Contact the firm by E-mail: recall@tobiiati.com or telephone: 1-800-793-9227.
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.
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.
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.