TriClipRecalls & reported problems across all models
St. Jude Medical, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 643
- Deaths reported
- 2
- Injuries reported
- 327
- Recalls
- 0
We found 7 models of TriClip by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 643 adverse event reports in the FDA's MAUDE database, received between May 7, 2024 and Sep 25, 2026 — classified as 2 deaths, 327 injuries, 314 malfunctions.
The most frequently reported specific device problem is “Incomplete Coaptation” (252 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TriClip problems
Device problems
- Incomplete Coaptation252
- Difficult to Open or Close78
- Leak/Splash69
- Unintended Movement54
- Difficult to Remove51
- Device Damaged by Another Device45
- Difficult or Delayed Positioning44
- Entrapment of Device43
Patient problems
- No Clinical Signs, Symptoms or Conditions434
- Tricuspid Valve Insufficiency/ Regurgitation120
- Unspecified Tissue Injury72
- Foreign Body In Patient23
- Dyspnea12
- Embolism/Embolus8
- Mitral Valve Insufficiency/ Regurgitation8
- Thrombosis/Thrombus7
TriClip models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TriClip™ TCDS0301-XTWTricuspid valve repair device, percutaneously delivered2 deaths287 reports
- TriClip™ TCDS0801-XTWTricuspid valve repair device, percutaneously delivered148 reports
- TriClip™ TCDS0301-XTTricuspid valve repair device, percutaneously delivered62 reports
- TriClip™ TSGC0201Catheter, percutaneous54 reports
- TriClip™ TCDS0801-XTTricuspid valve repair device, percutaneously delivered49 reports
- TriClip™ TSGC0801Catheter, percutaneous42 reports
- TriClip™ TCDS0801-NTWTricuspid valve repair device, percutaneously delivered1 report
Recent TriClip adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 25, 2026Leak/Splash; Air/Gas in 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 preparation, steerable guide catheter (SGC) would not hold the column. Air bubbles were observed. Device was replaced and continued the procedure. 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 50898591 ↗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 23, 2026Difficult to Insert; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874482 ↗InjurySep 23, 2026Leak/Splash
It was reported on (b)(6) 2026 that the patient presented with grade 4 functional tricuspid regurgitation (TR) for a TriClip procedure. During the procedure, loss of column was observed post dilater removal. Thrombus was noted on wire. Additional heparin was administered. Aspiration was performed for removal of thrombus. The TR was reduced to grade 1 post procedure. There was no clinically significant delay reported.
Patient problems: Thrombosis/Thrombus
MAUDE report 50873062 ↗InjurySep 18, 2026Leak/Splash; Air/Gas in Device
It was reported on (b)(6) 2026 that the patient presented with grade 3+ functional tricuspid regurgitation (TR) for a TriClip procedure. During the procedure, after removal of dilator loss of column and air were observed in hemostasis valve of TriClip Steerable Guide Catheter(TSGC). The TSGC was retracted into atrium. Aspiration was performed for removal of air. The loss of column was observed again. The TSGC was replaced with another device to complete the procedure. The TR was reduced to grade 1 post procedure. There was no clinically significant delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828612 ↗MalfunctionSep 18, 2026Difficult or Delayed Activation
It was reported that on (b)(6) 2026 a patient presented with grade 5 degenerative tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, while deploying triclip XT, actuator knob was turned 11 times, and the actuator knob was not released from the clip. Actuator knob was released when physician pulled the actuator knob out and the device was implanted. 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 50820190 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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