2005: “The year of the recall” - the aftermath and the road ahead

Published: 29 Mar 2006

By Dr. Sundheep Balu

The death of a 21 year old man in May 2005 due to a failed defibrillator and the events that followed, sparked a communal uproar and set the field for the media to highlight the failed devices in bad light. The medical device industry is familiar with device malfunctions and recalls, but the year 2005 saw highly publicized recalls and an aftermath that underscored inefficiencies in reporting protocols and safety standards.

Device recalls by all three of the leading companies in the Cardiac Rhythm Management (CRT) market set a succession of events which shook the CRM industry and slowed this fast growing segment temporarily.

In May 2005, Guidant Corporation reported that a hermetic sealing component used in some of its devices may gradually degrade and eventually result in the failure of the pacing activity of the device. It also reported that a shorting defect in one subset of its devices could lead to the failure of the device from producing the life saving shock to the patient. What followed next was the recall of thousands of devices in a short span of time and a direct hit to the credibility of the company in the market.

In February 2005, Medtronic, Inc. reported a problem in the battery of its CRT-D and ICD (Implantable caridoverter defibrillator) devices. This was followed by device recalls in the thousands and the urgent need to correct the malfunctions. Guidant Corporation and Medtronic, Inc were not the only ones to be plagued by this crisis. St. Jude Medical also reported a software problem with some of its ICD models as well.

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