TriClip™ TCDS0801-NTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067050816), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 3+ SEVERE FOCAL FUNCTIONAL POSTERIOR SEPTAL TRICUSPID REGURGITATION (TR), RESTRICTED SHORT SEPTAL LEAFLET FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP WAS PLACED ON THE MEDIAL SIDE OF POSTERIOR AND SEPTAL LEAFLET (P/S) BELOW THE TRICUSPID RING. TRICLIP WAS MOVED TO THE AORTIC, GRIPPERS WERE RAISED AND CLIP WAS UNLOCKED, IT WAS DETERMINED THAT THE CLIP WAS STUCK ON THE SEPTAL LEAFLET AND RING. TROUBLE SHOOTING WAS PERFORMED, BUT THE CLIP WAS UNABLE TO BE REMOVED FROM THE SEPTAL RING. SIGNIFICANT FORCE WAS REQUIRED TO REMOVE THE CLIP. THEREFORE, THE CLIP WAS DEPLOYED ON THE SEPTAL LEAFLET. ALL STEPS WERE PERFORMED AS PER IFU DURING THE PREPARATION. IMAGING WAS DIFFICULT DUE TO TRICUSPID RING. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL TR WAS UNCHANGED. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS OR ADVERSE PATIENT SEQUELA REPORTED.

  Patient problems: Foreign Body In Patient; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23721594 ↗