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# Safety Alert on Abbott’s MitraClip Delivery Systems
- URL: https://www.fdaweb.com/safety-alert-on-abbotts-mitraclip-delivery-systems/
- Published: 2022-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:58:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152698

An FDA [safety alert](https://www.fda.gov/medical-devices/letters-health-care-providers/abbott-mitraclip-device-potential-clip-lock-malfunctions-letter-health-care-providers?utm%5Fmedium=email&utm%5Fsource=govdelivery) is warning about potential clip lock malfunctions with Abbott’s MitraClip Delivery Systems. The company has issued an [Urgent Medical Device Correction](https://www.structuralheart.abbott/fileadmin/pdf/FINAL%5FAbbott%5FCorrection%5FNotification%5FUS%5FMitraClip%5FAbbott%5FWebsite%5Fsigned.pdf?ref=fdaweb.com) to inform health care providers about an increase in complaints regarding clip locking malfunctions, which have been observed before and after clip deployment. “These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models,” the alert says. The heart valve repair device was approved in 2013 to reduce [mitral regurgitation](https://medlineplus.gov/ency/article/000176.htm?ref=fdaweb.com) in certain patients.

“The potential risk to patients in the event of a clip lock malfunction includes ineffective treatment of mitral regurgitation and the potential need for additional interventions contributing to increased procedural risks such as bleeding, complications with implanting additional clips, and longer procedural times,” FDA says. “The majority of reported clip lock malfunction events have not been associated with adverse patient outcomes. Based on the available data on clip lock malfunctions and the associated risks, the FDA believes that the probable benefits of the MitraClip device continue to outweigh the probable risks for the approved indications for use.”