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Home » Medtronic Hit for Failing to Properly Investigate Reports of Device Failure
Medtronic Hit for Failing to Properly Investigate Reports of Device Failure
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility.
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