FDA Class I Recall: Medtronic HVAD Pump has defect

June 8, 2022

A release by the Food and Drug Administration (FDA) states that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect.

Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.

This issue can lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

FDA release

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