Monday, June 26, 2006

More Recalls for Boston Scientific

More bad news on some pacemakers, defibrillators and cardiac resynchronization devices from Boston Scientific (that acquired these devices from Guidant).


17:45 PM CST
Addendum - I spoke with our rep from Boston Scientific about this: They claim here is a bad lower voltage capacitor from one supplier that is faulty, but can lead unexpectedly to a no output state. There have been 5 reported device failures out of about 27,200 implants of the devices effected: one was caught pre-implant (low battery voltage), and 4 other patients required replacement of their device for low output state or premature battery depletion. Two of these replacement patients presented with loss of conciousness due to pacemaker output failure. The full physician notification can be found here and the patient notification letter can be found here.

No comments: