Check the voltage on certain implantable defibrillators, Guidant asks. Guidant Corp., which is being acquired for $27 billion by Boston Scientific Corp., cautioned doctors Monday to check the voltage on certain implantable defibrillators after the company received several reports of defective devices.
The Indianapolis-based medical device maker issued the warning for its Contak Renewal 3 RF and Contak Renewal 4 RF models of defibrillators, which are devices that shock the heart back to a normal rhythm.
Guidant said it had received 39 reports from doctors saying defibrillators that had been tested before being implanted had a lower-than-expected battery voltage. None of the 39 devices were put into patients.
4,000 Contak Renewal 3 RF and Contak Renewal 4 RF models have already been implanted
The voltage decline is related to a sustained, low level current that can only occur during storage and shipment before implantation. The company said about 4,000 Contak Renewal 3 RF and Contak Renewal 4 RF models have already been implanted, but it has not received any reports of this particular voltage problem.
Guidant said that the Food and Drug Administration may classify the notification to doctors as a product recall.
The company reminded doctors to check their inventory for the defect and to always perform the voltage check before implanting the device.
The notification follows a long line of product woes for Guidant that started in the summer when the company recalled thousands of pacemakers and defibrillators for a variety of reasons.