TriClip™ TSGC0801Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05415067050724), received between Sep 5, 2025 and Sep 25, 2026 — classified as 6 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (27 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 42 reports, in the reporter's own words as published by the FDA.

• 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 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 The TSGC was retracted into atrium.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 8, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674302 ↗
• MalfunctionSep 8, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674060 ↗
• MalfunctionSep 8, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673841 ↗
• MalfunctionAug 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254269 ↗
• InjuryAug 10, 2026Positioning Failure; Difficult to Remove

  It was reported that a TriClip procedure was performed to treat functional tricuspid regurgitation (TR) with a grade of 4 on patient with a restricted septal leaflet, prominent eustachian valve, and trileaflet. A TriClip steerable guide catheter (SGC) (60420R1038) and a TriClip XTW (50512R1005) clip delivery system (CDS) were prepared per the instructions for use (IFU), inserted, and grasping was performed. However, difficulties with imaging occurred. After multiple grasping attempts, leaflet inserted was achieved. However, difficulties with imaging occurred, the leaflets were unable to be deeply seated in the clip arms, and difficulties with trajectory occurred. The CDS was reset by removing ¿F ¿ knob and adding minus knob to be parallel with the intra-atrial septum of the superior vena cava (SVC). However, a ¿membrane of some sort¿ was observed in the atrium. In the physician¿s opinion, the ¿membrane¿ was not chiari network. At this time, the SGC and the CDS were at the original starting point, with the CDS approximately 1 ½ inches away from the tip of the SGC. However, tension was encountered, and imaging revealed that the CDS had retracted back to the SGC, and was lodged on the

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50193810 ↗
• MalfunctionAug 7, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174164 ↗
• MalfunctionAug 5, 2026Air/Gas in Device

  It was reported that on (b)(6) 2026, a patient presented with functional tricuspid regurgitation (TR) for a TriClip procedure. During device preparation, bubbles were identified when the TriClip was inserted within the clip introduction. Troubleshooting was performed and the clip was readjusted, during which the clip became caught on the clip introducer and tore the device with the grippers. The TCDS was removed from the patient and a replacement TriClip was selected and successfully implanted. Two additional TriClips were implanted successfully. The procedure was discontinued, the final TR was reduced. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147285 ↗
• MalfunctionJul 31, 2026Crack; Leak/Splash

  It was reported that on (b)(6) 2026, a patient presented for a Triclip procedure. During the preparation, dilator was removed from the triclip steerable guide catheter (TSGC) packaging in a sterile field on the back table. Three-way stopcock was attached to the dilator flush port and while the distal tip of the dilator was under the surface of heparin saline in a basin on the table, dilator was flushed while closing the Touhey valve. It was observed that tuohy valve on TSGC dilator has crack on it and leak was observed. Another TSGC was replaced and continued the procedure. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098238 ↗
• MalfunctionMay 4, 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), LOSS OF COLUMN WAS OBSERVED DURING WATER SEAL CHECK. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073070 ↗
• MalfunctionMay 1, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH TRICLIP REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION OF TRICLIP STEERABLE GUIDE CATHETER(TSGC), LOSS OF COLUMN WAS OBSERVED IN HEMOSTASIS VALVE. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059939 ↗
• MalfunctionApr 21, 2026Leak/Splash

  S 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), LOSS OF COLUMN WAS OBSERVED. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942027 ↗
• MalfunctionApr 20, 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, A TRICLIP WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS DISCONTINUED. AFTER THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE SGC FROM THE STABILIZER AND NEEDED MORE FORCE TO DETACH THE SGC. AFTER REMOVAL OF SGC WITH STABILIZER FROM THE PATIENT, IT WAS TESTED AND NOTED THAT IT REQUIRED MORE FORCE TO REMOVE IT. AFTER FEW ATTEMPTS, IT WAS NORMAL TO INSERT AND REMOVE. THE FINAL MR WAS REDUCED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931729 ↗
• MalfunctionApr 17, 2026Positioning Failure; Unintended Movement

  IT WAS REPORTED THAT DURING PREPARATION OF A TRICLIP STEERABLE GUIDE CATHETER (TSGC), PRIOR TO INSERTION, WHILE ATTEMPTING TO STRAIGHTEN THE TSGC, THE TGSC WAS NOT HOLDING POSITION, AND WENT BACK TO NEUTRAL. THE TSGC WAS SLIPPING BACK TO NEUTRAL. ALL STEPS WERE PERFORMED PER IFU. 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 24911964 ↗
• MalfunctionApr 13, 2026Leak/Splash; Air/Gas in Device

  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 COLUMN WAS OBSERVED. AIR BUBBLES WERE VISUALIZED. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858845 ↗
• MalfunctionApr 7, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE TRICLIP STEERABLE GUIDE CATHETER (TSGC) FROM THE STABILIZER. TROUBLESHOOTING WAS PERFORMED, AFTER SIGNIFICANT FORCE THE SGC WAS REMOVED FROM THE STABILIZER. THE FINAL TR WAS REDUCED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802120 ↗
• MalfunctionApr 2, 2026Difficult to Insert; Difficult to Remove

  IT WAS REPORTED ON 11 MARCH 2026 THAT THE PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP STEERABLE GUIDE CATHETER (TSGC) WAS UNABLE TO FIT INTO STABILIZER. DIFFICULTY WAS ENCOUNTERED WHILE REMOVING STABILIZER FROM TSGC. A REPLACEMENT TSGC WAS USED TO COMPLETE THE PROCEDURE. TWO TRICLIPS WERE IMPLANTED TO REDUCE THE TR TO GRADE 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769779 ↗
• MalfunctionMar 26, 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, LEAK WAS OBSERVED WHEN GUIDE WAS INVERTED. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705664 ↗
• MalfunctionMar 23, 2026Product Quality Problem; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION OF TRICLIP STEERABLE GUIDE CATHETER (TSGC), DAMAGE OF STEERABLE SHAFT WAS OBSERVED. THE TIP OF TSGC WAS OBSERVED TO BE CROOKED AND PERFORATION IN SHAFT WAS OBSERVED. THE TSGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE TR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663922 ↗
• MalfunctionMar 20, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4-5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. AFTER COMPLETING THE PROCEDURE, IT WAS UNABLE TO REMOVE THE TRICLIP STEERABLE GUIDE CATHETER (TSGC) FROM THE STABILIZER. TSGC WAS REMOVED FROM THE PATIENT WHEN IT WAS STILL ATTACHED TO THE STABILIZER. AFTER REMOVING FROM THE PATIENT, IT NEEDED MORE FORCE TO PULL TSGC FROM THE STABILIZER. ALL STEPS WERE FOLLOWED AS PER IFU. 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 24653426 ↗
• MalfunctionMar 18, 2026Difficult to Remove

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630050 ↗
• MalfunctionMar 13, 2026Difficult to Remove

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591263 ↗
• MalfunctionMar 10, 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, FIRST TRICLIP WAS IMPLANTED ON CENTRAL TO MEDIAL SIDE OF ANTERIOR AND SEPTAL LEAFLET AND SECOND TRICLIP WAS IMPLANTED ON MEDIAL SIDE OF POSTERIOR AND ANTERIOR LEAFLET. STEERABLE GUIDE CATHETER WAS REMOVED FROM THE PATIENT WHILE IT WAS STILL ATTACHED TO THE STABILIZER. GUIDE WAS UNABLE TO BE REMOVED FROM THE STABILIZER. AFTER MULTIPLE ATTEMPTS, FORCEPS WAS USED TO PUSH THE BACK PIN IN THE DIRECTION OF PATIENT'S HEAD. AFTER MULTIPLE ATTEMPTS, THE PIN PUSHED IN THE DIRECTION OF THE PATIENT HEAD AND WAS ABLE TO REMOVE THE GUIDE FROM THE STABILIZER. 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 24560907 ↗