TriClip™ TSGC0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05415067047748), received between May 31, 2024 and Aug 28, 2026 — classified as 11 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (34 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499182 ↗
• MalfunctionAug 27, 2026Leak/Splash

  It was reported that during preparation of the TriClip steerable guide catheter (TSGC), a loss of fluid column occurred. Therefore, the SGC was not used and the procedure was discontinued. There was no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50486138 ↗
• MalfunctionJul 27, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020451 ↗
• InjuryMay 27, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A CLIP WAS ATTEMPTED TO BE PLACED BUT WAS UNSUCCESSFUL SO THE CLIP WAS RETRACTED. WHILE RETRACTING THE CLIP INTO THE STEERABLE GUIDE CATHETER (SGC) IT BECAME CAUGHT. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND THE CLIP WAS SECURED TO THE SIDE OF THE SGC AND RETRACTED. A SMALL VASCULAR CUTDOWN PROCEDURE WAS PERFORMED AND THE CLIP WAS REMOVED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310319 ↗
• MalfunctionApr 17, 2026Break; Positioning Failure; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4-5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, WHILE APPLYING THE MINUS KNOB, IT WAS UNABLE TO STRAIGHTEN AS CABLE SNAPPED AND THERE WAS A POP SOUND. DEVICE WAS REPLACED AND CONTINUED THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913195 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, TRICLIP STEERABLE GUIDE CATHETER WOULD NOT HOLD THE COLUMN. DEVICE WAS REPLACED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718421 ↗
• MalfunctionMar 23, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF STEERABLE GUIDE CATHETER (SGC), LEAK WAS OBSERVED. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663701 ↗
• MalfunctionMar 20, 2026Leak/Splash; Air/Gas in Device

  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 PLACING THE SECOND CLIP ON THE LEAFLET, IT WAS OBSERVED THAT A TRICLIP STEERABLE GUIDE CATHETER (TSGC) WOULD NOT HOLD THE COLUMN AND AIR WAS PRESENT IN THE DEVICE. CLIP WAS IMPLANTED AND THE GUIDE WAS REMOVED FROM THE PATIENT. 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 24652646 ↗
• MalfunctionMar 11, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION OF TRICLIP STEERABLE GUIDE CATHETER(TSGC), LOSS OF FLUID COLUMN WAS OBSERVED DURING DILATOR INSERTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576349 ↗
• MalfunctionFeb 19, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (MR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, IT WAS NOTICED THAT THE GUIDE WOULD NOT HOLD THE COLUMN WHEN DILATOR WAS INSERTED. DEVICE WAS REPLACED AND THREE TRICLIPS WERE IMPLANTED. 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 24390249 ↗
• MalfunctionJan 29, 2026Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, WHEN TRYING TO APPLY THE MINUS ON THE TRICLIP STEERABLE GUIDE CATHETER (TSGC), IT WOULD NOT WORK. IT WAS NOTED THAT THE SGC WOULD TURN BUT WOULD NOT STRAIGHTEN. DEVICE WAS REPLACED AND CONTINUED THE PROCEDURE. 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 24217096 ↗
• MalfunctionDec 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, A TRICLIP STEERABLE GUIDE CATHETER (TSGC) WOULD NOT HOLD THE COLUMN. TSGC WAS REPLACED AND CONTINUED THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915655 ↗
• MalfunctionDec 29, 2025Difficult or Delayed Positioning; Difficult to Remove; No Apparent Adverse Event; Difficult or Delayed Positioning; Difficult to Remove; No Apparent Adverse Event

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4. A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP WAS THEN INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THERE WAS VERY LITTLE HEIGHT ABOVE THE VALVE AND DIFFICULT TRAJECTORY. AN ATTEMPT TO OPEN AND ORIENT THE CLIP WAS MADE, BUT THE CLIP ENDED UP UNDER ONE OF THE LEAFLETS. THE CLIP WAS INVERTED AND BROUGHT BACK TO THE RIGHT ATRIUM (RA). TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL UNABLE TO BE ACHIEVE A GOOD POSITION. AFTER SEVERAL ATTEMPTS, THE CLIP WAS RETRACTED BACK INTO THE STEERABLE GUIDE CATHETER (SGC). HOWEVER, IT WAS OBSERVED THAT THE SGC WAS INTERACTING WITH THE EUSTACHIAN VALVE. SEVERAL ATTEMPTS WERE MADE TO GET THE CLIP BACK INTO THE SGC. THEREFORE, A DECISION WAS MADE TO REMOVE THE CLIP. THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN INSERTED AND DEPLOYED ON THE TRICUSPID VALVE, REDUCING TR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL CLARIFIED INFORMATION WAS RECEIVED: FURTHER REV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907096 ↗
• MalfunctionDec 24, 2025Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL CLARIFIED INFORMATION WAS RECEIVED: IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 ON A PATIENT WITH A PROMINENT EUSTACHIAN VALVE. A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP WAS THEN INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THERE WAS VERY LITTLE HEIGHT ABOVE THE VALVE AND DIFFICULT TRAJECTORY. AN ATTEMPT TO OPEN AND ORIENT THE CLIP WAS MADE, BUT THE CLIP ENDED UP UNDER ONE OF THE LEAFLETS. THE CLIP WAS INVERTED AND BROUGHT BACK TO THE RIGHT ATRIUM (RA). TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL UNABLE TO BE ACHIEVE A GOOD POSITION. AFTER SEVERAL ATTEMPTS, THE CLIP WAS RETRACTED BACK INTO THE STEERABLE GUIDE CATHETER (SGC). HOWEVER, IT WAS OBSERVED THAT THE SGC WAS INTERACTING WITH THE EUSTACHIAN VALVE IN A WAY THAT WAS PREVENTING THE ABILITY TO STEER AND MANIPULATE THE CLIP DELIVERY SYSTEM (CDS) AS INTENDED. DUE TO THESE CHALLENGES, DIFFICULTY UNDERSTRADLING THE CLIP BACK INTO THE TSCG OCCURRED. SEVERAL ATTEMPTS WERE MADE TO GET THE CLIP BACK INTO THE SGC, AND THE CLIP WAS ULTIMATELY ABLE TO GE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889875 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721789 ↗
• MalfunctionNov 26, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660842 ↗
• MalfunctionNov 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND ENLARGED ATRIUM FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, TRICLIP STEERABLE GUIDE CATHETER(TSGC) WAS UNABLE TO HOLD COLUMN DURING DILATOR INSERTION. TROUBLESHOOTING WAS PERFORMED AND WAS SUCCESSFUL. THE TR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556156 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION, OF THE TRICLIP STEERABLE GUIDE CATHETER (TSGC) IT WAS IDENTIFIED THAT THE FLUID COLUMN WOULD NOT HOLD FLUID COLUMN. TROUBLESHOOTING WAS PREFORMED AND A NEW TSGC WAS SELECTED. THE FINAL TR WAS GRADE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525817 ↗
• MalfunctionNov 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND HORIZONTAL HEART FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS DIFFICULT. FIRST TRICLIP WAS IMPLANTED SUCCESSFULLY AT ANTERIOR SEPTAL LEAFLET. DURING DEPLOYMENT OF SECOND TRICLIP, DIFFICULTY WAS ENCOUNTERED WHILE INSERTING CLIP OVER CLIP INTRODUCER. TROUBLESHOOTING WAS PERFORMED AND WAS SUCCESSFUL. LEAFLETS WERE GRASPED AND THE CLIP WAS DEPLOYED. FIRST TRICLIP WAS OBSERVED TO BE DISLODGED FROM ANTERIOR LEAFLET AFTER DEPLOYMENT OF SECOND TRICLIP. AN ATTEMPT WAS MADE TO RETRACT THE SECOND TRICLIP FROM THE ANATOMY. DIFFICULTY WAS ENCOUNTERED WHILE RETRACTING CLIP THROUGH STEERABLE GUIDE CATHETER(SGC) AS BOTH THE GRIPPERS WERE UNABLE TO LOWER COMPLETELY. A TISSUE WAS OBSERVED ON THE CLIP AT THE BACK TABLE. THE TR INCREASED TO GRADE 5 POST PROCEDURE. PATIENT WAS IN STABLE CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501270 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A TRICLIP STEERABLE GUIDE CATHETER (TSGC), A LOSS OF FLUID COLUMN OCCURRED. THEREFORE, THE TSGC WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469760 ↗
• MalfunctionOct 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION OF TRICLIP STEERABLE GUIDE CATHETER(TSGC), GUIDE WAS UNABLE TO HOLD COLUMN AT HEMOSTATIC VALVE DURING DILATOR INSERTION INTO TSGC. TROUBLESHOOTING WAS PERFORMED THRICE AND WAS UNSUCCESSFUL. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442104 ↗
• MalfunctionOct 10, 2025Positioning Failure; Unstable; Positioning Failure; Unstable

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4DEGENERATIVE TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, WHILE REMOVING THE CLIP DELIVERY SYSTEM POST DEPLOYMENT OF THE CLIP, NO RESISTANCE WAS FELT WHILE TURNING NEGATIVE KNOB. THE TRICLIP STEERABLE GUIDE CATHETER(TSGC) WAS REMOVED FROM THE ANATOMY. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE TR WAS REDUCED TO GRADE <1 POST PROCEDURE. AT THE BACK TABLE, IT WAS OBSERVED THAT RESISTANCE WAS FELT WHILE TURNING L KNOB AND SHAFT WAS UNABLE TO CURVE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271483 ↗
• InjuryOct 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH FUNCTIONAL TRICUSPID REGURGITATION (TR) AND COR TRIATRIATUM DEXTER (CTD) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, AIR WAS OBSERVED INSIDE THE TRICLIP STEERABLE GUIDE CATHETER(TSGC) DURING RETRACTION OF DILATOR. ADDITIONAL ASPIRATION WAS PERFORMED OUTSIDE THE INSTRUCTION FOR USE UNTIL BLOOD WAS OBSERVED. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THE ISSUE PERSISTED AND THE PROCEDURE WAS TERMINATED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267688 ↗
• InjuryOct 10, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267645 ↗
• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP STEERABLE GUIDE CATHETER AND TRICLIP WERE ADVANCED IN RIGHT ATRIUM(RA). A THROMBUS WAS NOTICED ON THE WALL OF THE RA. THE TRICLIP WAS REMOVED FROM THE ANATOMY. AN ASPIRATION ATTEMPT WAS MADE TO REMOVE THROMBUS FROM THE ANATOMY. THE THROMBUS WAS NO LONGER VISIBLE IN IMAGING AND THE PROCEDURE WAS CONTINUED AS PER THE PROTOCOL. THE MR WAS REDUCED TO GRADE 3 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23184365 ↗