A mixed day for Medtronic

September 16, 2009 by MassDevice staff

The Minneapolis device giant wins a patent lawsuit against W.L. Gore, but its recall of subsidiary Physio-Control's Lifepak AED goes Class I.

Medtronic had a mixed day today, as it announced a win in a patent infringement suit, but the Food & Drug Administration slapped its Physio-Control LifePak CR defibrillator with its most severe level of recall.

First, the bad news: The Minneapolis device giant's Redmond, Wash.-based Physio-Control subsidiary's recall of the Lifepak CR Plus automated external defibrillator was labeled Class I by the FDA, meaning the device could cause serious injury or death.

That's because extreme humidity could cause the 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, are affected by the recall; Physio-Control contacted customers and sent replacements August 19.

Now for the good news: The settlement of Medtronic's lawsuit against Saugus, Mass.-based W.L. Gore & Associates over patents covering self‐expanding medical devices that use a metal alloy like nitinol that expands to its original shape after deployment.

The company sued Gore over the alleged infringement earlier this year. Terms of the settlement were not disclosed.

Medtronic took the first round of a similar lawsuit against AGA Medical Corp. last month, winning a $57 million jury decision in that case.