FDA Investigating Boston Scientific’s Defibrillator Recall
|Date Posted: March 19, 2010|
The FDA is investigating Boston Scientific’s voluntary recall of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
The Natick, Mass.-based company announced on March 15 that it had stopped shipping and began retrieving all of its ICDs and CRT-Ds that had not be implanted because it had made some changes to the manufacturing process for the devices without submitting proper notification for approval to the FDA.
“A planned process review revealed that two manufacturing process changes were not submitted for FDA approval,” said Ray Elliott, president and chief executive officer of Boston Scientific. “We are acting voluntarily and expeditiously to resolve this situation and we have seen no evidence of any risk to patient safety.”
The family of products involved in the recall includes Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality defibrillators.
In a statement released March 19, the agency advised healthcare practitioners not to use the devices “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.
The company has informed the FDA that it will submit a premarket approval supplement for review.
Additional information on the FDA investigation and the recall will appear in the May 2010 edition of Guide to Medical Device Regulation.