Guidant Corporation’s Cardiac Rhythm Management group, now a subsidiary of Boston Scientific, has announced yet another recall of its implantable heart devices. It is recalling 22,600 of a specific subset of pacemakers and defibrillators that were not a part of any previous recall due to a defective part that may deplete the batteries of the devices or cause them to malfunction. Another 27,200 of the devices are already implanted in patients and may suffer from the same defect. People who have the devices currently implanted are urged to consult their doctors for tests to determine whether the devices are functioning properly.

This new batch of recalls includes cardiac resynchronization pacemakers and implantable cardioverter defibrillators that contain defective low-voltage capacitors. Some of the capacitors may lead to premature battery depletion or intermittent or permanent loss of therapy, leading to inappropriate sensing of heart rhythm. Five adverse events have been confirmed by Guidant’s CRM division with these devices, including two events where patients lost consciousness as a result. No deaths have been reported.

The devices included in this recall are:

• Guidant INSIGNIA pacemakers
• Guidant NEXUS pacemakers
• Guidant CONTAK RENEWAL TR cardiac resynchronization pacemakers
• Guidant CONTAK RENEWAL TR2 cardiac resynchronization pacemakers
• Guidant VITALITY implantable cardioverter defibrillators
• Guidant VITALITY 2 implantable cardioverter defibrillators
• Guidant VENTAK PRIZM 2 implantable cardioverter defibrillators

Boston Scientific and Guidant are advising doctors to schedule an in-clinic visit with patients as soon as possible to assess the function of their implanted devices in order to determine if they have this defect. While the companies have stated that it believes there may be only two to three additional devices out of this recall that may be defective, “We will have further recalls,” James Tobin, Boston Scientific’s chief executive, said. “I also know that everybody in the industry will have further recalls.”

Guidant has identified the supplier of the defective capacitors traced to this latest safety issue, but said it will not be able to complete an overhaul of its quality control systems by the fourth quarter of this year as demanded by the U.S. FDA in a January warning letter. Boston Scientific has decided to have independent auditors review its quality control changes before it has the FDA approve them, contributing to the delay.

Patients are advised to discuss any concerns with their doctors or contact Guidant Patient Services:

Guidant Corporation 4100 Hamline Ave. North St. Paul, MN 55112 1-866-GUIDANT (1-866-484-3268)

Sources: Sylvia Pagan Westphal, “Pacemakers Flagged in Fresh Recall,” Wall Street Journal, June 27, 2006; Barnaby J. Feder,” Thousands of Devices for Hearts are Recalled,” New York Times, June 27, 2006; FDA Release, June 26, 2006; Guidant Letter to Patients, June 23, 2006, accessed June 27, 2006.