The Food & Drug Administration (FDA) says it is investigating last week’s massive<"https://www.yourlawyer.com/practice_areas/defective_medical_devices"> recall of implantable defibrillators by Boston Scientific. As we reported previously, Boston Scientific halted sales and began retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15. The company said it did so because it did not get approval from the FDA for changes to its manufacturing processes.
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.
In a statement released March 19, the FDA advised healthcare practitioners not to use the recalled defibrillators “unless and until the agency reviews and approves the changes the company has made.†The FDA also said that it is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.
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. Companies are required to submit notification of these types of changes to the FDA for evaluation prior to marketing and distribution.
According to The Boston Globe, Boston Scientific’s lapse was related to documentation, the paperwork that companies are required to submit to the FDA whenever they make material changes in their production processes.
Boston Scientific has informed the FDA that it will submit a premarket approval supplement to the agency for review.
