A Medical Device Daily
Medtronic (Redmond, Washington) reported voluntarily recalling "a limited number" of Lifepak 500 automated external defibrillators (AEDs).
The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected, according to the company. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed.
Medtronic said it has received 54 incident reports related to this specific group of Lifepak 500 AEDs, including eight instances "where it may have prevented patient resuscitation," corresponding, it said, "to less than 1% of patient uses.
The Lifepak 500 is used by first responders trained in CPR/AED use, and first to arrive at the scene of a cardiac incident, but not having significant medical training.
The action affects 1,924 first-generation Lifepak 500 AEDs manufactured in 1997, or about 1% of Lifepak 500 AEDs now in use worldwide. This action does not affect any other Lifepak 500 AEDs currently produced, or any other Lifepak product, the company said.
Also, "a recently completed theoretical engineering analysis estimates that this issue may occur on up to 8% of patients," it said.
Medtronic said it sent certified mail notices on Feb. 3 to customers who purchased AEDs in this group of devices and that it will update or upgrade customer devices at no charge by March 31, 2005. The affected AEDs may remain in service, and customers are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic Lifepak 500 AEDs manufactured in 1997 are included in this action.
The company said it has notified the FDA of the recall, with the agency classifying it as a Class I recall, defined as "a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death."
In another Class I recall, the FDA has recalled the IV Flush brand of heparin or sodium chloride intravenous catheter flushes made by IV Flush (Rowlett, Texas), devices used to flush intravenous catheter lines with either heparin or saline solution.
The Dallas district office of the FDA said that the devices were marketed without proper agency clearance and "are suspected to be contaminated with Pseudomonas flourescens, a pathogenic bacteria."
The agency said that these preloaded syringes should not be used and immediately should be returned to the company or to the original distributor, Pinnacle Medical Supply (also Rowlett).