TriClip™ TCDS0801-XTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 05415067050731), received between Jun 12, 2025 and Sep 25, 2026 — classified as 68 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (61 reports).

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 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899665 ↗
• InjurySep 25, 2026Incomplete Coaptation

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50899655 ↗
• MalfunctionSep 25, 2026Unintended Movement

  It was reported that on (b)(6) 2026 a patient presented with grade 5 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, first establish final arm angle (EFAA) was passed, lockline was removed. During second first establish final arm angle (EFAA), clip failed. Clip was removed from the patient and was replaced with another clip. All steps were performed as per IFU. The final TR was grade 2. There were no adverse patient effects or clinically significant delays reported

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899617 ↗
• MalfunctionSep 25, 2026Incomplete Coaptation

  It was reported on (b)(6) 2026 that the patient presented with grade 5+ functional tricuspid regurgitation (TR) and rotated heart for a TriClip procedure. Imaging was sub-optimal due to previous cardiac surgery. During the procedure, a TriClip was successfully implanted.During deployment sequence of second TriClip XTW, the clip had single leaflet device attachment (SLDA) from the anterior leaflet. Additional TriClip was further implanted. The TR was reduced to grade 3+ post procedure. There was no clinically significant delay or adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898985 ↗
• InjurySep 25, 2026Positioning Failure; Entrapment of Device

  It was reported that on (b)(6) 2026 a patient presented with grade 5 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, while trying to grasp the leaflets first triclip, it was unable to grasp both the leaflets. It was observed that lateral leaflet was caught between the gripper and the shaft of clip delivery system (CDS). Multiple maneuvers were attempted to freed the clip but was unsuccessful. Clip was deployed on chordae and lateral leaflet. Additional clip was implanted to stable the first clip. All steps were performed as per IFU. Imaging was difficult. The final TR was grade 3. There were no adverse patient effects or clinically significant delays reported

  Patient problems: Foreign Body In Patient

  MAUDE report 50898580 ↗
• InjurySep 23, 2026Incomplete Coaptation

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50875894 ↗
• InjurySep 23, 2026Positioning Failure

  Patient problems: Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 50875731 ↗
• MalfunctionSep 18, 2026Break; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820164 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026 a patient presented with grade 4 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, first triclip XTW was inserted into the right atrium through guide, it appeared that there might be clot on the clip. Clip was removed from the guide for the inspection. Triclip was replaced with the new clip and continued the procedure. All steps were performed as per IFU. The final TR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50820036 ↗
• MalfunctionSep 15, 2026Positioning Failure; Deformation Due to Compressive Stress; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777000 ↗
• InjurySep 15, 2026Difficult to Remove

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, transesophageal echocardiogram (TEE) probe was not able to enter the stomach due to esophageal restriction. Mid and deep esophageal views were adequate, and ICE imaging was adequate and physician decided to proceed. Right access was attempted and could not advance guide to the right atria due to torturous and restricted iliac. Attempt was made with the left access; it was difficult to advance and eventually advanced triclip steerable guide catheter (TSGC) into the right atria. Due to tortuosity, it was difficult for septal and lateral movements of the guide to translate. First triclip was attempted but ended up pulling back to inferior, physician decided to remove the clip and wanted to replace it with teh new clip. Second triclip XTW was introduced into the right atria, steered down to the tricuspid valve and was aligned in the atria within the desired location. Leaflets were grasped and due to less impact on the TR, physician moved the clip more central and crossed under the valve for the second attempt. During the second att

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50775754 ↗
• InjurySep 15, 2026Entrapment of Device

  It was reported that on (b)(6) 2026 a patient presented with grade 4 functional tricuspid regurgitation (TR), long lateral leaflets and rotated heart for a Triclip procedure. During the procedure, while under the valve, leaflets became attached to the shaft and gripper of another clip arm and would not release. There was good grasp of septal leaflet, and the clip was deployed and was stable. Additional clip was attempted but was not implanted due to the anatomy. Imaging was difficult. All steps were performed as per IFU. The final TR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50774007 ↗
• MalfunctionSep 15, 2026Unintended Movement

  It was reported that on (b)(6) 2026 a patient presented with grade 4+ functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, first triclip was implanted. While implanting the second clip, clip opened during first test the lock. It was noted that clip angle was 20 degrees before opening and 50-60 degrees after opening. Troubleshooting was performed and the clip was deployed. All steps were performed as per IFU. The final TR was grade <1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773920 ↗
• MalfunctionSep 15, 2026Unintended Movement

  It was reported that on (b)(6) 2026 a patient presented with grade 4 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, triclip opened to about 15 degrees. Troubleshooting was performed and the clip was implanted. All steps were performed as per IFU. The final TR was grade <1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773697 ↗
• MalfunctionSep 14, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764627 ↗
• MalfunctionSep 14, 2026Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764624 ↗
• InjurySep 14, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, first triclip was implanted on medial side of anterior and septal leaflet (A/S). Post deployment, it was determined that there was a single leaflet device attachment (SLDA) and the clip was no longer attached to the anterior leaflet. Second triclip XT and third triclip XTW was implanted to stabilize the SLDA. The final TR was grade 1-2. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762752 ↗
• InjurySep 14, 2026Premature Activation; Difficult to Remove

  It was reported that on (b)(6) 2026, a patient presented with grade 4-5 degenerative tricuspid regurgitation (TR), dilated atrium for a Triclip procedure. During the procedure, tissue got stuck in the closed clip. It was unable to be removed. Clip started coming off from the release pin and was only attached to the lockline. Clip was pulled back into inferior venacava and into the femoral vein. Small incision was made to remove the system. Patient was sutured and procedure was attempted on the left side successful. It was noted that femoral vein was damaged. All steps were performed as per IFU. The final TR was grade <1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Perforation of Vessels; Unspecified Tissue Injury

  MAUDE report 50762691 ↗
• InjurySep 11, 2026Incomplete Coaptation

  It was reported that a TriClip procedure was performed to treat functional tricuspid regurgitation (TR) with a grade of 5+ on a patient with 4 leaflets with a central gap and a previous aortic valve replacement and a previous left atrial appendage (LAA) closure device. A TriClip was inserted and deployed on the tricuspid valve. However, difficulties visualizing the clip occurred, and post deployment, the clip detached from the anterior leaflet and remained attached to the other leaflet (single leaflet device attachment/SLDA). A second clip, a TriClip XTW was then inserted and deployed on the tricuspid valve, reducing TR to a grade of 4-5. There was no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736864 ↗
• InjurySep 11, 2026Incomplete Coaptation

  It was reported that a TriClip procedure was performed to treat functional tricuspid regurgitation (TR) with a grade of 3-4 on a patient with thin leaflets. A TriClip XTW was inserted and deployed on the tricuspid valve without issues, reducing TR to trace.However, after the procedure, the patient coded (cardiac arrest), and cardiopulmonary resuscitation (CPR) was performed, and the patient was administered protamine. A transesophageal echocardiogram (TEE) was performed and revealed that the clip had detached from the septal leaflet and remained attached to the other leaflet (single leaflet device attachment/SLDA). The patient had return of spontaneous circulation (ROSC) after 2 minutes. It was noted that one physician's opinion was that the patient coded due to the SLDA, but another physician's opinion was that the patient coded due to the administration of protamine. The patient was reported to be stable, awake, and talking. No additional information was provided.

  Patient problems: Cardiac Arrest; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50736624 ↗
• MalfunctionSep 11, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736337 ↗
• MalfunctionSep 11, 2026Positioning Failure; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735334 ↗
• MalfunctionSep 9, 2026Incomplete Coaptation; Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699172 ↗
• InjuryAug 26, 2026Entrapment of Device

  It was reported that on (b)(6) 2026, a patient presented with grade 4 mixed tricuspid regurgitation (TR) and an enlarged atrium for a TriClip procedure. During the procedure, while steering the TriClip into the tricuspid valve, the clip became entangled with lateral chordae. Troubleshooting was performed unsuccessfully and the clip was implanted on the septal and anterior leaflets with chordae. The clip remained stable after deployment, but a second TriClip was implanted to secure the first TriClip and further reduce the TR. The procedure was discontinued; the final TR was reduced to grade 2. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457003 ↗
• InjuryAug 25, 2026Incomplete Coaptation

  It was reported on 06 August 2026 that the patient presented with grade 4 mixed tricuspid regurgitation (TR), enlarged atrium, prolapsed anterior and thin leaflet for a TriClip procedure. Imaging was sub-optimal due to patient's complex anatomy. During the procedure, a TriClip was successfully implanted.Post deployment, the clip had single leaflet device attachment (SLDA) from the septal leaflet. An attempt was made to deploy second clip for stabilization of SLDA, although the clip was removed from the anatomy as significant TR reduction was unable to be achieved. The TR remained unchanged post procedure. There was no clinically significant delay reported.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50431669 ↗