Guidant Defibrillator History

Guidant Defibrillator History

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Of the 3.8 billion dollars Guidant made in 2004, 1.9 billion of that came from its successful and widely distributed Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Devices. These miraculous devices monitor heart rate in patients at risk for ventricular fibrillation, spastic and chaotic heartbeats that can quickly cause the heart to seize up and cease blood circulation. These devices must be of the highest quality, for people rely on ICDs to save their lives if they go into fibrillation.

Since Guidant was incorporated in 1994, they have sold more that 50,000 ICDs to people who count on them every day. Unfortunately, quality began to suffer in 2002, when Guidant discovered that the insulation on some of the wiring in three models of ICD could accidentally short out and prevent the unit from functioning properly. Instead of halting production and recalling the units, Guidant decided to continue to sell faulty devices and address the malfunction in later models.

There were approximately 45 malfunctions and two deaths associated with this short circuit. Guidant later announced that an additional four models have memory programming errors that may prevent them from delivering the therapy they are intended to perform. The recall not only affects the 50,000 people who have these life-saving devices, but anyone who has faith in trust in the medical device industry. If these machines, which have a normal success rate of more than 90% be subject to a recall, what other, less reliable machines are waiting out there to fail?


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