Sunday, June 26, 2005

Now Stuck Switches for Guidant

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

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