Boston Scientific Suspends Defibrillator Implant Sales

Boston Scientific Corp. has suspended sales of its heart-shocking defibrillator implants after failing to keep regulators in the loop about changes it had made in manufacturing the devices, according to published reports.

Company officials said the defibrillators are safe but that Boston Scientific failed to meet a requirement to submit documents to the U.S. Food and Drug Administration (FDA) with notification of production process changes.

The Natick, Mass.-based company said it will recall all the affected devices from suppliers and hospitals, according to the reports.

According to Rick Wise of Leerink Swann, who said he spoke to a regulatory consultant, how quickly this issue is resolved will depend on Boston Scientific’s stance with the FDA and how proactive it is in tackling issues. The consultant told Swann that the best case scenario is a resolution could come in days. Other options include a 30-day notice process or a 180-day supplement review process.

Wise said every two weeks Boston Scientific’s devices remain off the market, it could cost $24M in sales.

Boston Scientific was not immediately available for comment.