Defibrillator Manufacturer Expands Recall
Medtronic Inc. is expanding its February recall of external defibrillators, adding another 396 units to the 1,924 devices identified two months ago, the U.S. Food and Drug Administration announced.
The Lifepack 500 devices may not properly analyze the patient's heart rhythm, even when its electrodes are properly connected, the FDA said in a statement. Failure to properly analyze heart rhythm may inhibit the device's ability to regulate a fluttering heartbeat.
The device is used by firefighters, police officers, and others trained in CPR who are often the first to respond to a cardiac incident, but who lack significant medical training.
Affected devices were produced in 1997. For more information, contact Medtronic at 1-877-873-7630, or visit the company's Web site at www.medtronic-ers.com/500.
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