FDA has issued a Class I recall for LIFEPAK CR Plus automated external defibrillators (AEDs) produced by Medtronic’s subsidiary Physio-Control, Inc. This urgent medical device recall was issued for 249 LIFEPAK CR Plus units manufactured between 4/2004 and 8/2007 and distributed until the end of 2007.
Class I FDA recalls of medical devices are the most serious form of recall reserved for medical equipment that can cause catastrophic injury. As the FDA states:
Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
The recalled Medtronic automated external defibrillators (AEDs) were configured with software intended for a different Medtronic product, resulting in a medical device that may not work or work accurately in emergency situations. Automatic external defibrillators deliver an electrical shock to restore heart rhythm in persons suffering potentially fatal heart irregularities (cardiac arrhythmia or ventricular tachycardia).
The Medtronic LIFEPAK CR Plus defibrillators, by design, is a fully automated medical device. In actuality, the Medtronic device was programmed with software intended for a semi-automated device that includes voice prompts to push buttons that are not accessible to emergency personnel. These battery-powered units are located in public places for potable emergency usage.
It is reported Medtronic has received at least one case of a problem associated with this defective medical device.
Replacements LIFEPAK defibrillator devices were shipped at the beginning of September with a warning from the Medtronic subsidy that the defective CR Plus devices should not be used or have the covering over the shock buttons be removed. There is no report of how many defective LIFEPAK AED devices are still in use.
If you or a loved one in Tennessee has suffered injury from this recalled Medtronic device or personal injury from another defective medical device, the law offices of the Higgins firm would like to help. Contact our downtown Nashville law office at (615) 353-0930 or fill out our Tennessee personal injury attorney form for a free initial consultation with a defective medical device lawyer.