| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | 
| | | Today, the FDA issued a Letter to Health Care Providers to alert about the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction. Medtronic issued an Urgent Medical Device Correction to inform health care providers of the pump weld defect and is conducting an investigation to identify which HVAD pumps may be affected. As stated in the FDA's June 2021 communication, the FDA does not recommend the elective removal of properly functioning systems at this time. Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients together on a case-by-case basis, considering the patient's clinical status and surgical risks. The Letter to Health Care Providers includes important information about the HVAD System, including: - Recommendations for health care providers.
- Actions the FDA continues to take to monitor the safety and effectiveness of the HVAD Systems that remain implanted.
- Instructions for reporting problems with a device.
Questions? If you have questions about Medtronic HVAD System, contact the Division of Industry and Consumer Education (DICE). | | | |
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