MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to alert them about the potential for clip lock malfunctions with MitraClip Delivery Systems manufactured by Abbott, and to ensure providers are aware of the manufacturer’s recall notice and recommended actions.

The Letter to Health Care Providers includes important information about the potential for clip lock malfunctions, including:

• Recommendations for health care providers.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with Abbott MitraClip Delivery Systems to the FDA.

Questions?

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education (DICE).