The recall is due to a welding defect that could lead to corrosion and demagnetization of the internal magnets, potentially causing the pump to rotate incorrectly. There have been one death and two injuries reported with the welding defect.
The HVAD system aids the heart in pumping blood throughout the body for patients in late-stage heart failure awaiting a transplant.
Medtronic notified physicians with an urgent medical device correction letter April 26 about the potential of a defect, according to the FDA.
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