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# FDA Warns on Medtronic Heartware Ventricular Assist Device
- URL: https://www.fdaweb.com/fda-warns-on-medtronic-heartware-ventricular-assist-device/
- Published: 2022-04-29T12:00:00.000Z
- Updated: 2026-09-14T17:42:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151713

FDA is warning healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may instead have a welding defect in the internal pump causing the pump to malfunction. According to a just-released Medtronic [Urgent Medical Device Correction](https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-medical-device-notice-update-may-2022.pdf?ref=fdaweb.com), the company is conducting an investigation to identify which HVAD pumps may be affected. Meanwhile, the agency has issued a [letter](https://www.fda.gov/medical-devices/letters-health-care-providers/potential-internal-pump-malfunction-medtronic-hvad-system-letter-health-care-providers?ref=fdaweb.com) to healthcare providers to make them aware of the problem and recommend actions to take to manage patient care.

FDA continues to stand by a [6/2021 communication](https://www.fda.gov/medical-devices/letters-health-care-providers/stop-new-implants-medtronic-hvad-system-letter-health-care-providers?ref=fdaweb.com) that did not recommend the elective removal of properly functioning systems. “Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency says.

The HVAD is approved as a bridge to heart transplantation in patients who are at risk of mortality from end-stage left ventricular heart failure, for heart tissue recovery, and as destination therapy in patients for whom a heart transplant is not planned.