FDA Statement on Boston Scientific Recall of Implantable Cardioverter Defibrillators
The Food and Drug Administration has been notified by Boston Scientific Corporation that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.

The 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. The 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.

Boston Scientific stated it initiated its voluntary recall due to manufacturing changes that were not submitted to the FDA for review as required. Companies are required to submit a notification of any change in manufacturing procedures or methods of manufacturing that affect the safety or effectiveness of the devices. Companies are required to submit notification of these types of changes to the FDA for evaluation prior to marketing and distribution. Boston Scientific has informed the FDA that it will submit a premarket approval supplement to the agency for review.

The FDA is currently investigating the matter.