Boston Scientific Issues Broad Retrieval of ICD, CRT-D, Halts Shipping of New Devices

Shelley Wood

Disclosures

March 15, 2010

March 15, 2010 (Natick, Massachusetts) — Device giant Boston Scientific dropped a bomb on day 2 of the American College of Cardiology 2010 Scientific Sessions/ i2 Summit, announcing it was retrieving all field inventory and halting new shipments of its entire US line of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)--not for safety reasons, but because of a manufacturing process change that had not been given the green light by the FDA [1].

"At this time, the company has identified two instances of changes that, while successfully validated, were not submitted to the FDA," the release states. "Boston Scientific has informed the FDA and plans to work closely with the agency to resolve this situation as soon as possible."

The advisory doesn't apply to pacemakers or other devices but encompasses all of the company's ICDs and CRT-Ds: the COGNIS, CONFIENT, LIVIAN, PRIZM, RENEWAL, TELIGEN, and VITALITY brand devices.

"We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety," nor is explantation of devices being recommended, Ray Elliott, president and chief executive officer of Boston Scientific, said in a press statement. "We apologize for the inconvenience these actions will cause patients and physicians."

Analyst reports were among the first to trumpet the news, even before Boston Scientific issued its alert. Larry Biegelsen of Wells Fargo Securities predicted early this morning that the news will mean "reputational damage" for the company, despite the fact that the problem appears to be "administrative."

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