Pacemakers have occasionally been the subject of recalls after malfunctions were cited as potential causes of injury.
In June 2009, the U.S. Food and Drug Administration alerted patients about a recall of certain Medtronic Kappa and Sigma pacemakers, saying they might fail due to a problem with its wires. It said patients with malfunctioning pacemakers could experience lightheadedness or fainting and, in rare cases, serious injury or even death.
Recalled were about 21,000 Medtronic pacemakers, most of them at least five years old. They were the Kappa Series 600/700/900 and the Sigma series 100/200/300.
In late 2005, Guidant Corp. recalled 170,000 Insignia and Nexus pacemakers due to malfunctions. The devices were subject to sudden loss -- both intermittent and permanent -- of pacing output or loss of telemetry without warning.
The recall affected about 56 percent of the company's pacemakers. Guidant said it was aware of nine emergency hospitalizations caused by pacemaker malfunctions but no deaths, according to MedPage Today, a website that provides medical-related news.
It said the FDA had noted failures in the Insignia pacemakers dating back to 2003, with the most recent occurring in July 2005.
Kline & Specter, PC, based in Philadelphia and with some 30 lawyers (several of whom are also highly regarded doctors) has handled pacemaker cases and has successfully litigated many product liability and mass tort lawsuits, particularly in Pennsylvania and New Jersey. At this time, Kline & Specter is no longer accepting cases involving defective pacemakers.
- Widow of a man who died after his pacemaker malfunctioned filed a medical malpractice suit against the doctor who installed the device.(Full story)
- The Heart Rhythm Society said today that the FDA should tighten up post-market surveillance of pacemakers and implantable cardioverter defibrillators.
- The Heart Rhythm Society, a group of electrophysiologists, called today for independent watchdog committees to monitor both the manufacturing and regulation of pacemakers and implantable cardioverter-defibrillators.