| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | | The U.S. Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because: - There is an increased risk of neurological adverse events and mortality associated with the internal pump.
- There is a potential for the internal pump to stop. If the internal pump stops, it may delay restarting or fail to restart.
Both problems may lead to mortality or serious injuries. Therefore, health care providers should no longer implant the Medtronic HVAD System. Health care providers should continue to manage care of patients with a previously implanted Medtronic HVAD System according to the instructions in the Medtronic Urgent Medical Device Communication Notification letter. The Letter to Health Care Providers includes important information about the Medtronic HVAD System, including: - Details on safety issues related to the device.
- Recommendations for health care providers.
- Actions the FDA has taken to monitor adverse events associated with the Medtronic HVAD System.
- Instructions for reporting problems with the HVAD System to the FDA.
Questions? If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE). | | | |
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