Boston Scientific Corp. warned physicians that three of its implantable defibrillators have a defect that can prevent them from working properly, in the latest problem for the company's heart devices.The original physician communication, dated today, can be found in pdf format here.
A magnetic switch on the implantable cardiac defibrillators can get stuck, stopping the devices from delivering an electric shock to the hearts of patients who need the therapy, the company said in a letter to doctors.
The Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs were made in 2006 and 2007, and about 34,000 remain implanted in patients, according to the Natick, Mass., company, which said on Thursday that it had issued the advisory.
It is unclear how Boston Scientific learned about the problem, and why it issued the advisory now. A company spokeswoman didn't immediately respond to requests for comment.
Boston Scientific said in its product advisory that the risk of harm was remote, and it hasn't received any reports of deaths or injuries. Doctors have replaced some of the devices, according to the advisory, but the company recommends against it.
08:20AM 23 Jul 2010: The Boston Scientific 'Dear Doctor' letter (pdf) regarding the advisory.