Boston Scientific will soon resume shipment and sales of some <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">defibrillators it recalled last month. According to The Wall Street Journal, the Food & Drug Administration (FDA) has approved two manufacturing changes that the company had not cleared with the agency when they were implemented.
Boston Scientific’s failure to notify the FDA of the manufacturing changes prompted it to halt sales and began retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15. 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.
The recall impacted seven brands of Boston Scientific defibrillators: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion.
According to the Journal, Boston Scientific plans to have its Cognis and Teligen defibrillators back on sale within 24 hours. Those devices account for most of the company’s implant volume in the U.S.
However, five older devices are still on hold, following disclosure by the company that it found some other manufacturing changes that should have been cleared by the FDA. It will be about three to four weeks before sales of those implants resume.
This disclosure of another paperwork snafu relating to the older devices could cause additional problems for Boston Scientific, the Journal said. One analyst quoted in the report said the revelation increases the odds that the firm will be issued an FDA warning letter over the episode.
Boston Scientific already faces investigations by the Department of Justice and the Securities and Exchange Commission over the recall, as well as a shareholder lawsuit.
