Reports of Battery Failure Prompt Recall of Zoll AED Plus Defibrillator

At Least 2 Deaths Associated with Device Failure

Zoll Medical Corporation in conjunction with the FDA has issued a Class 1 Recall of its ZOLL AED Plus Defibrillator, manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009.

This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients having a heart attack (cardiac arrest). However, the company has received reports that following a long period (typically greater than 4 years) without use, a ZOLL AED Plus may prompt "change batteries" during use and fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

In their March 31 customer letter, Zoll states "Although this issue was identified through customer reports from non-clinical testing there has been one clinical event reported in which a defibrillation shock was not delivered, the patient subsequently died, and our evaluation of the device found that the batteries experienced the identified problem. At this time we have reviewed all reported patient events and found up to 3 additional cases in which a shock was not delivered to a patient, and the battery may have experienced the identified problem. We were informed that in 1 of the cases the patient subsequently died."

APRIL-10-09: Class 1 Recall: ZOLL AED Plus Defibrillator [FDA: ZOLL AED DEFIBRILLATOR RECALLED]

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Published on Apr-10-09