Defibrillator Recall


Guidant Corporation has just recalled thousands of cardiac defibrillators around the world because of potentially fatal failures with the devices. This recall happened on Friday, June 17 2005 after at least two deaths have occurred since the end of May. As of now there are about 38,000 patients in the US with Guidant brand defibrillators and reports have indicated these machines have failed 45 times so far.

The FDA said in a statement that they did not mandate Guidant to recall their products, but still supported the decision.

Guidant has known that there were potential problems with the Prizm 2 DR model defibrillator, however they continued to market it but demanded a complete redesign of the unit. The model had failed on a few occasions before 2002, but Guidant claimed that the new revisions would make it safer. Later, in 2004, doctors discovered that Contak Renewal defibrillators built before August 26, 2004 demonstrated a high risk of short circuiting and failing to function properly.

When Guidant was presented with these two problems they decided it was in their best interest to publicly recall their defective products. This however is providing little comfort to the 50,000 people who continue to live in constant fear that their life-saving equipment might fail them when they need it most.

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Author: Piyawut Sutthiruk

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