Defective Heart Defibrillators

Defective implanted heart defibrillators have been the subjects of many recalls over the last several years. This week, Boston Scientific Inc., advised doctors that a part in certain models of its implanted heart defibrillators made in 2006 and 2007 has a “somewhat higher’’ failure rate, requiring units to be reprogrammed. The company reported a failure rate of one in 670 devices. No deaths or injuries have been reported.
Boston Scientific estimates that about 34,000 patients still have the defibrillators implanted, even though they are no longer sold.
Boston Scientific temporarily recalled its defibrillators in March of this year after failing to notify US regulators of manufacturing changes. In April, the company recorded $1.8 billion in costs from the withdrawal. The company said the recall will result in the loss of four percentage points this year from the company’s share of the US defibrillator market.
A magnetic switch on the implantable cardiac defibrillators can get stuck, stopping the devices from delivering an electric shock to the hearts of patients who need the therapy, the company said in a letter to doctors.
The devices involved are the Contak Renewal 3, Contak Renewal 4 and Vitality HE.
According to the company’s website, the defect can by resolved by reprogramming the devices, and replacement is not necessary.

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