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FDA not strict enough with medical device recalls

Vital life-dependent medical devices are poorly tracked in the United States, unnecessarily risking patients’ lives. For example, a 39 year-old Utah woman received a Guidant implant pacemaker device in 2003. The woman was never notified that Guidant, with the FDA’s full knowledge, had issued safety advisories for her new pacemaker. She lived with the faulty device until complications forced its removal in 2004 – the same year that Guidant issued a recall of the device. The recall was not soon enough: the Utah woman’s use of the faulty device exacerbated her already fragile condition.

The FDA needs to be stricter with forcing recalls. Need statistics for proof? There are approximately 8,000 new medical devices marketed in the U.S. each year. There are approximately 200,000 adverse event reports received by the FDA yearly. Only 1,000 medical devices are recalled each year.

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