Medtronic Hit for Failing to Properly Investigate Reports of Device Failure

By Sam | February 4, 2021

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.
Source: The GMP Letter