Recall for Boston Scientific Defibrillators Lifted, Sales to Resume

The FDA is allowing several heart implants to go back on the market after a temporary recall of Boston Scientific defibrillators was issued last month due to unannounced manufacturing changes. 

The FDA said last week that Boston Scientific could resume sales of its implantable cardiac defibrillators (ICDs) after a 30-day review of the products. In March, Boston Scientific announced that it had inadvertently failed to inform the agency of two manufacturing changes in the devices, resulting in the recall. The action has sparked investigations by the Department of Justice (DOJ) and the Securities Exchange Commission (SEC).

Prior to the recall being issued, Boston Scientific was already under a legal cloud for earlier actions of its Guidant subsidiary, which recently plead guilty to DOJ charges that it attempted to cover up problems with defective defibrillator implants by not informing the FDA of design changes meant to fix flaws that were sometimes fatal to implant recipients. The company will pay a record $296 million medical device manufacturing criminal fine.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. Boston Scientific said it issued the most recent ICD recall after it realized that it had made two manufacturing changes that were not approved by FDA, which is a regulatory requirement. Boston Scientific described the incident as a clerical oversight and said that there had been no safety issues related to the changes. The FDA must approve the changes before the devices can be put back on the market.

Boston Scientific announced what it said was an oversight in mid-March, sparking th 30-day review by FDA of the company’s documentation on the ICDs and the changes they made. After the review was complete, FDA has allowed the ICDs to go back on the market. However, the FDA reportedly found other issues and instances of oversights in how the company handles ICD manufacturing during the review. These issues are likely to be expressed in a future warning letter from FDA.