Boston Scientific Announces Ship Hold and Inventory Retrieval of ICD and CRT-D Devices
Boston Scientific Corporation announced on March 15 that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA). Boston Scientific states that it has no indication that the manufacturing process changes pose any risk to patient safety, and it is not recommending explantation of the devices. Visit the Boston Scientific website to read March 15 announcement »
In its March 22 "Dear Physician" letter, Boston Scientific noted that in a March 18 press release, the FDA referred to this product removal action as a recall. Boston Scientific states, "It is important to understand that this action is in response to a regulatory filing omission rather than a product quality or patient safety issue. There are no indications that these manufacturing changes pose any risk to patient safety. There have been no device failures associated with these manufacturing changes nor are any failures expected in the future. Boston Scientific is not recommending device explantation or any changes to normal follow-up procedure for patients implanted with our ICD or CRT-D devices." - Boston Scientific's "Dear Physician" letter (PDF, 33K), March 22
- Boston Scientific's "Dear Patient" letter (PDF, 26K), March 22
- Read posting on MedWatch: The FDA Safety Information and Adverse Event Reporting Program, "FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted. Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.
- Read Additional Statement by FDA
Health care facilities affected by this product removal have been informed and supported by their local Boston Scientific sales representative. The company asks that if any Boston Scientific ICDs or CRT-Ds remain in hospital inventory, the hospital is to contact its local representative, +1 (800) 227-3422, for pick up and return.
