Monday, June 20, 2005

More Short Circuits for Guidant

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

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