Medtronic Recalls Lifepak DefibrillatorsSep 12, 2008 | Parker Waichman LLP
Medtronic Inc. is recalling some of its portable Lifepak Automated External Heart Defibrillators because the button that activates the device is inaccessible. The Food & Drug Administration (FDA) classified the action as a Class 1 recall, meaning there is "a reasonable probability" of "serious adverse health consequences or death."
The recall involves 249 LifePak CR Plus Automated External Defibrillator with Product Number: 3200731-003 and 3200731-027. The defibrillators were manufactured by Medtronic's Physio Control unit between May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007.
These LifePak CR Plus Automated External Defibrillators are used by emergency or medical personnel, or by others who have taken the appropriate training to use the device. The devices are intended to treat adults in cardiopulmonary arrest (heart attack). They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
Medtronic said it has received one patient-related complaint associated with the faulty devices. According to the recall notice, the device instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).
Medtronic said Physio Control began calling customers about the problem on August 28. The company will be replacing the defective devices. The company also sent a follow-up letter that was FAXed or emailed the same day stating that the customers should immediately perform one of the following actions:
- Remove the affected AEDs from service or
- Remove and discard the shock button cover (a diagram showing what to do was enclosed).