Medtronic Inc. (NYSE:MDT) subsidiary Physio-Control is causing its parent company headaches again, this time with a Class I recall of its LifePak 15 monitor/defibrillator.
The Food & Drug Administration’s classification if the recall as Class I means the agency believes the device can cause “serious adverse health consequences or death.”
Medtronic said there have been no “adverse patient events” related to the issue. The recall applies to versions of the LifePak 15 monitor/defibrillator that were manufactured before Dec. 16, 2009.
Physio-Control said the affected devices were manufactured with an internal component that could cause an electrical short that leads to the device turning off or on by itself or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy.
Physio-Control said it notified affected customers of the problem March 4 and has begun servicing the devices for free. The company recommends that customers continue using the device but test it following its operating instructions.
It’s not the first Class I recall for Physio-Control’s LifePak line. In September 2009, the FDA made the pull-back of its LifePak CR defibrillator a Class I recall.
Extreme humidity could cause that AED to improperly analyze patients’ heart rhythms, prompting a delay or failure to deliver a shock to restore the heart to its normal tempo. Only devices made between July 9 and August 19, 2008, wer affected by the recall; Physio-Control contacted customers and sent replacements August 19, 2009.
The latest blow to Physio-Control comes after the company received some good news in February. At the time, the FDA gave the company approval to resume selling its automated external defibrillators, which Physio-Control voluntarily stopped shipping in 2007 due to concerns about its quality-control procedures.
The problems with the FDA prevented Medtronic from moving forward with a planned spin-off of Physio-Control. Medtronic said in December that the spin-off was on hold until at least the end of fiscal 2010.
In February, CEO Bill Hawkins was noncommittal about when Medtronic would resume divesting the business. He said the company would wait because it needed time to restore relations with its customers.