MITRACLIPRecalls & reported problems across all models

We found 8 models of MITRACLIP by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 5,973 adverse event reports in the FDA's MAUDE database, received between Oct 28, 2016 and Sep 1, 2026 — classified as 149 deaths, 3,378 injuries, 2,446 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (1,551 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

MITRACLIP recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 8, 2022Open, Classified

   An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

   Z-0116-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 8, 2022Open, Classified

   An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

   Z-0115-2023 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗

Most reported MITRACLIP problems

MITRACLIP models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MITRACLIP CDS0701-XTW

  Mitral valve repair devices
  1 recall33 deaths1,524 reports
• MITRACLIP CDS0701-NTW

  Mitral valve repair devices
  1 recall22 deaths959 reports
• MITRACLIP SGC0701

  CATHETER, STEERABLE
  17 deaths963 reports
• MITRACLIP CDS0601-XTR

  Mitral valve repair devices
  1 recall30 deaths873 reports
• MITRACLIP CDS0601-NTR

  Mitral valve repair devices
  1 recall21 deaths641 reports
• MITRACLIP CDS0701-NT

  Mitral valve repair devices
  1 recall12 deaths430 reports
• MITRACLIP CDS0701-XT

  Mitral valve repair devices
  1 recall6 deaths271 reports
• MITRACLIP CDS0501

  Mitral valve repair devices
  8 deaths312 reports

Recent MITRACLIP adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJul 31, 2026Entrapment of Device

  It was reported that on (b)(6)2026, a patient presented with grade 5 degenerative mitral regurgitation (MR) and a prolapsed posterior leaflet for a MitraClip procedure. During the procedure, a MitraClip was advanced within the patient. While positioning the clip it became caught on the chordae tendinea. Troubleshooting was performed and the clip remained entraped on the leaflets when tissue damage was visualized. The procedure was discontinued, the MR remained at grade 5. There were no clinically significant delays reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50101260 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ degenerative mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a MitraClip was advanced within the patient. During grasping attempts the MitraClip XTR caused a tear on the posterior leaflet. The Mitraclip was removed from the patient and the procedure was discontinued without implanting any MitraClips. The final MR remained at grade 4+. There were no clinically significant delays reports.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25871292 ↗
• InjuryJun 3, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, TWO MITRACLIPS WERE IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. IT WAS REPORTED THAT ON (B)(6) 2026, A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED AND IT WAS IDENTIFIED THAT THE PATIENTS MR HAD INCREASED TO GRADE 3. THE PATIENT WAS TRANSITIONED INTO A PROCEDURE FOR A SECONDARY MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT ONE OF THE PREVIOUSLY IMPLANTED CLIP HAD A SINGLE LEAFLET DETACHMENT (SLDA) AND WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. AN ADDITIONAL CLIP WAS IMPLANTED BESIDE THE SLDA CLIP FOR STABILIZATION. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382848 ↗
• InjuryMay 12, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 3+FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP NTR WAS SUCCESSFULLY PLACED ON THE LEAFLETS WHEN THE MEAN PRESSURE GRADIENT (MPG) WAS MEASURED TO BE 10 MMHG. THE CLIP WAS REMOVED, AND THE PROCEDURE WAS DISCONTINUED WHEN THE MPG RETURNED TO BASELINE. THE FINAL MR REMAINED AT GRADE 3+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT HAD A FOLLOW-UP EXAMINATION WHEN IT WAS IDENTIFIED THAT THE MR INCREASED TO GRADE 4+. A POSTOPERATIVE ULTRASOUND IDENTIFIED TISSUE DAMAGE TO THE VALVE LEAFLETS. THE PATIENT REMAINED IN THE HOSPITAL FOR CONTINUED MEDICATION TREATMENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Unspecified Tissue Injury

  MAUDE report 25152733 ↗
• InjuryApr 21, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ ON A PATIENT WITH A PROLAPSED POSTERIOR LEAFLET, THICK LEAFLETS, A CALCIFIED VALVE ANNULUS, AND A PREVIOUS TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) SURGERY. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XTR WERE INSERTED WITHOUT ISSUES. HOWEVER, LIMITED BENDING MANIPULATION WITH THE SGC OCCURRED, WHICH RESULTED IN DIFFICULTY WITH POSITIONING OF THE SGC AND UNEVEN CLAMPING WITH THE MITRACLIP XTR. THE MITRACLIP XTR WAS ULTIMATELY DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1+. AFTER THE SGC WAS REMOVED FROM THE PATIENT, THE SGC WAS TESTED AND THE SGC TIP WAS BENDING NORMALLY. ON (B)(6) 2026, ONE WEEK POST PROCEDURE, THE PATIENT DEVELOPED CHEST TIGHTNESS. AN ULTRASOUND WAS PERFORMED AND REVEALED THAT THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE TO A GRADE OF 4+. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Angina; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24942067 ↗
• InjuryApr 16, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY PLACED ON THE LEAFLETS AND DEPLOYED. AFTER DEPLOYMENT, THE CLIP OPENED TO APPROXIMATELY 30 DEGREES. THE PROCEDURE WAS DISCONTINUED. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED ON THE PATIENT AND IT WAS IDENTIFIED THAT THE MR RETURNED. THE PATIENT'S HEART RATE AND BLOOD PRESSURE REMAINED STABLE, THE PATIENT WAS TREATED WITH MEDICATION AND REMAINS HOSPITALIZED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24905174 ↗
• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THERE WAS A LEAK IN THE STEERABLE GUIDE CATHETER (SGC) FROM THE HEMOSTASIS VALVE. THE SGC WAS REMOVED FROM THE PROCEDURE AND A REPLACEMENT SGC WAS SELECTED. A MITRACLIP WAS ADVANCED WITHIN THE PATIENT AND ATTEMPTED TO BE PLACED ON THE LEAFLETS. IT WAS IDENTIFIED THAT THE POSTERIOR LEAFLET WOULD NOT DESCEND. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND THE CLIP WAS ATTEMPTED TO BE REMOVED FROM THE PROCEDURE. IT WAS NOT POSSIBLE TO REMOVE THE CLIP AND THE PATIENT WAS CONVERTED TO SURGERY. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873587 ↗
• InjuryApr 13, 2026Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 ON A PATIENT WITH A PRE-EXISTING FLAIL AND FRIABLE LEAFLETS. A MITRACLIP XTW WAS IMPLANTED, REDUCING MR TO A GRADE OF 2-3. ON (B)(6) 2026, THE PATIENT RETURNED TO THE HOSPITAL WITH SYMPTOMS OF SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED THAT THE CLIP HAD PARTIALLY DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED FULLY ATTACHED TO THE ANTERIOR LEAFLET (PARTIAL CLIP MOVEMENT), CAUSING MR TO INCREASE TO A GRADE OF 4. IT WAS NOTED THAT THE NEW ISSUE WAS ATTRIBUTED TO DETERIORATION OF LEAFLET QUALITY, AND THAT THE FLAIL HAD GOTTEN WORSE SINCE THE FIRST PROCEDURE. A SECOND MITRACLIP PROCEDURE WAS PERFORMED, AND TWO CLIPS WERE IMPLANTED, REDUCING MR TO A GRADE OF 1-2.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Unspecified Tissue Injury

  MAUDE report 24866631 ↗
• MalfunctionApr 8, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS ADVANCED WITHIN THE STEERABLE GUIDE CATHETER (SGC) WHEN AIR BUBBLES WERE VISUALIZED WITHIN THE SGC. TROUBLESHOOTING WAS PREFORMED AND IT WAS IDENTIFIED THAT THE HEMOSTATIC VALVE WAS DAMAGED. THE MITRACLIP AND SGC WAS REMOVED FROM THE PATIENT, REPLACEMENT DEVICES WERE SELECTED. THE REPLACEMENT MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE FINAL MR WAS REDUCED TO <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821755 ↗
• 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 ↗

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