21,000 Medtronic Pacemakers Recalled Due to Malfunction Risk

About 21,000 implanted pacemakers made by Medtronic Inc. have just been ordered recalled because wires inside the devices that connect the electronic circuit to the battery and other components might break, the Food and Drug Administration said.

The Class I recall is the most urgent such action the FDA can take when a medical device or drug represents an unreasonable probability of failing and causing adverse health consequences or death.

The company’s Kappa Series 600/700/900 and Sigma Series 100/200/300 models of pacemakers are covered by the recall. There have been more than 1.7 million of the devices implanted in patients worldwide, but only 21,000 of them are included in today’s recall. Many of the devices involved in the recall have been implanted in patients for five years or longer, the FDA said.

Pacemakers may be implanted inside the bodies of patients diagnosed with irregular heartbeat or other life-threatening cardiac conditions. The devices deliver electrical charges to the heart to correct episodes of arrhythmia and keep the heart beating properly.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness, the FDA said. In some cases, a defective pacemaker may result in serious injury or even death.

Patients who are carrying the recalled models of Kappa and Sigma pacemakers should call Medtronic at 1-800-505-4636 or visit the company’s web site for further instructions.

On May 18, Medtronic notified physicians of the potential for problems with the two models of pacemakers, the FDA said. The company then notified patients who have the pacemakers in a letter sent on May 27.

Other Medtronic Product Recalls

Medtronic has been in hot water before due to potential problems with its heart devices. In October 2007, the company recalled four models of its Sprint Fidelis heart defibrillator leads because the wires that connect a defibrillator to the heart might fracture.

The defective wires could prevent the defibrillators from sending a life-saving electric shock to the heart when needed to stop a heart attack or cause the devices to send painful shocks when not needed.

In February 2005, Medtronic recalled some of its implantable defibrillator models, which might fail suddenly due to defective batteries. The Medtronic Insync cardiac resynchronization therapy defibrillator, Maximo ICD, and Marquis ICD models were involved in that 2005 recall. They were implanted in patients in 2001, 2002, and 2003, officials said.

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