Boston Scientific Corp. is recalling all of its implantable heart defibrillators because it failed to notify regulators of manufacturing changes. The company said it had no indication that the manufacturing changes threatened the safety of patients who have the defibrillators, and it didn’t recommend that doctors remove devices implanted in patients. Boston Scientific described the situation as a documentation problem, saying it was working with the FDA to resolve the issue “as soon as possible.”
The FDA has warned Boston Scientific on prior occasions for failing to follow reporting requirements. In 2006, the agency warned the company about failing to report problems in its devices and barred Boston Scientific from introducing most new products in the U.S. until the deficiencies were corrected. In 2007, the company was cited for failing to report two deaths in a clinical trial. The latest problems are expected to exact a heavy toll. Defibrillators accounted for 15% of Boston Scientific’s U.S. revenue last year.
Boston Scientific informed the FDA that it hadn’t filed for approval and would withdraw its devices. The FDA requires that companies get permission before making such changes, to ensure device safety and effectiveness aren’t compromised, and the review typically takes 30 days.
While the company did not use the word “recall” in a short statement, instead saying it was stopping shipment and retrieving products already distributed, the FDA said Boston Scientific’s action was a recall. Boston Scientific didn’t identify the manufacturing changes that sparked the problems. The company says it made sure the changes complied with FDA quality rules, but failed to ask the FDA to approve them.
Implantable cardioverter defibrillators, or ICDs, are potential life-savers. The small devices, placed in the chests of patients, give electronic jolts to hearts that are beating abnormally to get them to return to a normal rhythm. The devices are a significant segment of the medical-device industry’s business, generating $4.3 billion in U.S. revenue last year.
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