Monday, July 18, 2005

Now It's Guidant's Pacemakers that Spring Leaks

From the New York Times, another story about faulty products from Guidant. The company just announced that the "hermetic sealing component" in a variety of its older pacemaker models "may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case," leading to failure. 28,000 pacemakers still implanted out of 78,000 manufactured in the Pulsar, Pulsar Max, Discovery, Meridian, Virtus Plus II, Intellis II and Contak model lines are affected.
Guidant's CEO Robert W. Dollens stated "the health and safety of our patients is paramount. Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients."
Guidant has previously reported several problems with its implantable cardiac defibrillators (see our posts here and here.) In addition, as detailed in the links in the latter post, Guidant withheld information about some of these problems from physicians and the public, and continued to sell older versions of the devices from inventory that included a known design flaw even after it had started manufacturing improved versions that were not flawed. Guidant's CEO and other executives have been sued for securities fraud for concealing these problems while the company was in merger negoations (see this post).
Guidant seems to represent the many troubled organizations which collectively are an important cause of health care dysfunction, but one rarely discussed outside of Health Care Renewal. (We had noted how a recent long interview with Guidant's CEO Dollens in Health Affairs barely touched on any of these issues.)

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