Boston Scientific Defibrillator Recall: Unapproved Manufacturing Changes

Boston Scientific has been forced to recall several models of implantable heart defibrillators after failing to notify the FDA that it made changes to the devices’ designs. 

The company announced that it was stopping shipment and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in a press release on March 15. The company said that it decided to pull the devices from the market after realizing that some changes in how the devices were manufactured were not submitted to FDA for approval, as required by federal law. The FDA has classified the action as a medical device recall.

The implants are used to monitor patients’ hearts for abnormal heart rhythms and then deliver electric shocks to keep the heart beating at the proper rhythm.

Boston Scientific says that it does not believe there is any safety concern for people who have had the devices implanted, and have classified the defibrillator recall as a filing error. However, analysts say that the recall of the defibrillators, which account for 15% of the company’s revenue, could cost $5 million per day until the manufacturing processes are approved.

The recall comes less than a month after the Department of Justice filed criminal charges against Guidant LLC, a Boston Scientific subsidiary, for allegedly hiding information regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs that, in some cases, resulted in death. Boston Scientific announced last November that it intends to pay $296 million in connection with the charges against Guidant. The DOJ says it expects that Boston Scientific is likely to enter a guilty plea in connection with the charges.

The criminal charges are related to earlier defibrillator manufacturing changes that prosecutors say were done to cover up deaths from defective defibrillator designs. The DOJ charges say that Guidant failed to inform the FDA of the changes in order to avoid scrutiny. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.

The Prizm series, which was included in the criminal investigation, is also one of the units affected by the latest recall for unapproved manufacturing changes. Other defibrillator lines affected by the recall include the Cognis, Confient, Livian, Renewal, Teligen and Vitality ICDs and CRT-Ds.

Boston Scientific says it plans to work closely with FDA to get the manufacturing changes approved and quickly make the defibrillators available on the market again.