MITRACLIP SGC0701Recalls & reported problems

Summary

The FDA's MAUDE database contains 963 adverse event reports that list this exact device (DI 08717648231025), received between Dec 3, 2019 and Sep 1, 2026 — classified as 17 deaths, 404 injuries, 542 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (497 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 963 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Difficult to Insert; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549665 ↗
• MalfunctionAug 27, 2026Leak/Splash

  It was reported that on (b)(6) 2026, a patient presented for a mitraclip procedure. During the preparation, mitraclip steerable guide catheter would not hold the column, and the leak was observed at the hemostatic valve. Device was replaced and continued the procedure. All steps were performed as per IFU. The final MR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478934 ↗
• MalfunctionAug 7, 2026Leak/Splash

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR) and restricted posterior leaflet for a Mitraclip procedure. During the preparation, It was noticed that hemostatic valve on the back of the guide catheter was not holding column when dilator was inserted. Device was replaced and continued the procedure. All steps were performed as per IFU. The final MR 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 50174521 ↗
• MalfunctionApr 3, 2026Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER WOULD NOT HOLD THE COLUMN WHEN INTRODUCING THE DILATOR. AIR BUBBLES WERE OBSERVED WITHIN THE DEVICE. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. 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 24779705 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF STEERABLE GUIDE CATHETER(SGC), HEMOSTASIS VALVE WAS UNABLE TO HOLD COLUMN. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715676 ↗
• MalfunctionMar 12, 2026Break; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN AND HEMOSTASIS VALVE WAS BROKEN. 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 24580803 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A THROMBUS WAS OBSERVED ON THE GUIDE WHILE INSERTING INSIDE ANATOMY. TPA (TISSUE PLASMINOGEN ACTIVATOR) MEDICATION WAS ADMINISTERED. ASPIRATION WAS PERFORMED FOR REMOVAL. A MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO GRADE 2 POST PROCEDURE. CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24471177 ↗
• InjuryFeb 6, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), ENLARGED ATRIUM AND PROLAPSED LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE CLIP OPENED TO 30-40 DEGREE POST DEPLOYMENT. PARTIAL CLIP MOMENT WAS OBSERVED POST OPENING. ANOTHER MITRACLIP WAS DEPLOYED TO STABILIZE THE OPENED CLIP. PER THE PHYSICIAN, STEERABLE GUIDE CATHETER (SGC) WAS UNABLE TO HOLD COLUMN AFTER REMOVING THE FIRST CLIP. ASPIRATION RESOLVED THE ISSUE. THE MR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278919 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD COLUMN. SGC WAS REPLACED AND CONTINUED THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216683 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, THE STEERABLE GUIDE CATHETER (SGC) WAS UNABLE TO HOLD COLUMN. 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 24215345 ↗
• MalfunctionJan 20, 2026Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF STEERABLE GUIDE CATHETER (SGC), UPON INSERTING THE DILATOR INTO THE GUIDE, GUIDE HAS LOST THE COLUMN, RESULTED IN HEMOSTATIC VALVE FILLING WITH AIR. THE THREE-WAY STOP-COCKS WERE TIGHTENED AFTER THE FIRST ATTEMPT AND CHANGED STOPCOCKS FOR THE SECOND AND THIRD ATTEMPT OF PREPARATION OF GUIDE. SGC WAS DISCARDED AND REPLACED WITH NEW SGC, BUT PROCEDURE WAS DISCONTINUED AS PHYSICIAN WAS UNABLE TO ADVANCE THE TRANSEPTAL WIRE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122626 ↗
• MalfunctionJan 6, 2026Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973205 ↗
• InjuryJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FLAIL LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, WHEN CLIP WAS PLACED INTO THE BODY, AIR BUBBLES WERE OBSERVED IN THE PATIENT AND GUIDE HAD LOST COLUMN. GUIDE WAS REPLACED AND CONTINUED THE PROCEDURE, AND TWO MITRACLIPS WERE IMPLANTED. THE FINAL MR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Air Embolism

  MAUDE report 23950413 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN WHEN DILATER INSERTED IN THE HEMOSTATIC VALVE. TWO ATTEMPTS WERE MADE. ALL STEPS WERE FOLLOWED AS PER IFU. SGC 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 23950344 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND PROLAPSED LEAFLETS. FOLLOWING TRANSSEPTAL PUNCTURE, A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND MITRACLIP XTW WAS THEN INSERTED. HOWEVER, A PERICARDIAL EFFUSION WAS OBSERVED. TO TREAT THE PERICARDIAL EFFUSION, PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS STABILIZED. THE SECOND CLIP WAS DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO TRACE. IN THE PHYSICIAN¿S OPINION, THE PERICARDIAL EFFUSION WAS DUE TO THE TRANSSEPTAL PUNCTURE. THERE WERE NO DEVICE ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 23890738 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN AS DILATOR ENTERED INTO BACK OF GUIDE AND IT WAS REPLACED WITH NEW SGC. 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 23821307 ↗
• MalfunctionDec 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, WHILE INSERTING THE DILATOR, STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN. IT WAS REPLACED WITH NEW SGC AND CONTINUED THE PROCEDURE AND IMPLANTED TWO NTW MITRACLIPS. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810902 ↗
• MalfunctionDec 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN WHILE PLACING THE DILATOR INSIDE THE GUIDE. THE SGC WAS FLUSHED SEVERAL TIMES, AND CHANGED STOPCOCKS, BUT WHENEVER THE DILATOR WAS PLACED INSIDE THE SGC, IT WOULD LOSE THE COLUMN AND FILLED WITH AIR. THE SGC WAS REPLACED AND CONTINUED THE PROCEDURE AND WAS SUCCESSFUL. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810852 ↗
• MalfunctionDec 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 3-4 FUNCTIONAL MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, A STEERABLE GUIDE CATHETER (SGC) DID NOT HOLD THE COLUMN. IT WAS REPLACED WITH NEW SGC AND CONTINUED THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777518 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 13 NOVEMBER 2025, THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, EFFUSION AND HYPOTENSION WERE NOTED. ANESTHESIA SUPPORT MAINTAINED BLOOD PRESSURE STABILITY. TWO MITRACLIPS WERE SUCCESSFULLY IMPLANTED. THE EFFUSION SUBSEQUENTLY WORSENED. PERICARDIOCENTESIS WAS USED TO RESOLVE EFFUSION AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PATIENT IS IN STABLE CONDITION. ACCORDING TO THE PHYSICIAN, THE EFFUSION MAY HAVE OCCURRED DURING TRANSEPTAL PUNCTURE AND/OR DILATION WITH THE STEERABLE GUIDE CATHETER (SGC)/DILATOR. THE MR WAS REDUCED TO GRADE 2+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23760351 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS LOSS OF FLUID COLUMN AT THE HEMOSTATIC VALVE AFTER FIRST CLIP DELIVERY SYSTEM (CDS) WAS REMOVED FROM STEERABLE GUIDE CATHETER (SGC). THE FINAL MR WAS GRADE <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721731 ↗
• InjuryDec 2, 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+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A SMALL TISSUE WAS OBSERVED AT THE END OF STEERABLE GUIDE CATHETER(SGC) IN THE LEFT ATRIUM POST REMOVAL OF DILATOR AND WIRE. A NON-ABBOTT CATHETER WAS USED TO ASPIRATE THE TISSUE. TISSUE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS CONTINUED WITH DEPLOYMENT OF THE CLIP. THE MR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23699148 ↗
• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF STEERABLE GUIDE CATHETER(SGC), THE GUIDE WAS UNABLE TO HOLD COLUMN WHILE DE-AIRING. THE CHECK WAS PERFORMED TWICE AND THE ISSUE PERSISTED. A G5 SGC REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697746 ↗
• InjuryNov 21, 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 MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A THROMBUS WAS OBSERVED ON THE GUIDEWIRE IN THE RIGHT ATRIUM. HEPARIN MEDICATION WAS GIVEN TO THE PATIENT. ASPIRATION WAS PERFORMED FOR REMOVAL OF THROMBUS AND WAS UNSUCCESSFUL. THROMBUS WAS INITIALLY OBSERVED ON TRANSEPTAL WIRE AND IS BELIEVED TO BE MOVED BY STEERABLE GUIDE CATHETER (SGC). THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23619028 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED INTO THE LEFT ATRIUM WHEN AIR WAS IDENTIFIED WHILE WITHDRAWING THE DILATOR. AIR WAS REMOVED WITH A SMALLER, SECONDARY CATHETER PLACED THROUGH THE GUIDE. THE SGC WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR WAS GRADE 2. ALL STEPS WERE PERFORMED AS PER IFU. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Air Embolism

  MAUDE report 23594031 ↗