MitraClipRecalls & reported problems across all models

We found 9 models of MitraClip by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,986 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2022 and Sep 30, 2026 — classified as 67 deaths, 1,562 injuries, 1,357 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (751 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

Most reported MitraClip problems

MitraClip models

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

• MitraClip™ CDS0706-XTW

  Mitral valve repair devices
  31 deaths1,341 reports
• MitraClip™ CDS0706-NTW

  Mitral valve repair devices
  13 deaths448 reports
• MitraClip™ CDS0801-XTW

  Mitral valve repair devices
  5 deaths335 reports
• MitraClip™ CDS0706-XT

  Mitral valve repair devices
  7 deaths282 reports
• MitraClip™ SGC0801

  Catheter, percutaneous
  2 deaths177 reports
• MitraClip™ CDS0706-NT

  Mitral valve repair devices
  4 deaths170 reports
• MitraClip™ CDS0801-XT

  Mitral valve repair devices
  3 deaths115 reports
• MitraClip™ CDS0801-NTW

  Mitral valve repair devices
  1 death69 reports
• MitraClip™ CDS0801-NT

  Mitral valve repair devices
  1 death49 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 30, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952127 ↗
• InjurySep 30, 2026Unintended Movement

  It was reported that a MitraClip procedure was performed to treat degenerative mitral regurgitation (MR) with a grade of 4+ on a patient with thick leaflets and a pre-existing flail. A MitraClip XTW was inserted and placed on the mitral valve. However, during deployment, after pulling the lock line lever, the clip relaxed slightly, but within normal limits. The clip was deployed on the mitral valve. However, after deployment, the clip opened from approximately 20 to 60 degrees. It was noted that the clip remained stable on the leaflets. To stabilize the clip, a second clip was then inserted and deployed medial and adjacent to the first clip, reducing MR to a grade of 1. There was no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952061 ↗
• InjurySep 30, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951811 ↗
• MalfunctionSep 29, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940222 ↗
• MalfunctionSep 29, 2026Difficult to Open or Close; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940086 ↗
• InjurySep 29, 2026Positioning Failure; Difficult to Remove

  It was reported that a MitraClip procedure was performed to treat functional mitral regurgitation (MR) with a grade of 4 on a patient with a restricted posterior leaflet. A MitraClip XTW was inserted and grasping was performed. However, difficulties visualizing the clip occurred, he leaflets were unable to be grasped or captured, and the clip became caught in chordae. Troubleshooting was performed, and the clip was able to be freed from chordae, and the clip was removed from the patient. However, at the end of the procedure, a small flail was observed likely due to subvalvular interaction. The procedure was discontinued with no clips implanted. There was no clinically significant delay in the procedure.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50938411 ↗
• MalfunctionSep 29, 2026Break; Difficult or Delayed Positioning; Difficult to Open or Close

  It was reported that on 04 September 2026 a patient presented with grade 4 functional mitral regurgitation (MR) for a Triclip procedure. During the procedure, posterior gripper would not lower or raise. Troubleshooting was performed but was unsuccessful. It was decided to remove the clip from the patient and was observed that gripper line was broken. Another mitraclip XT was implanted successfully. Imaging was difficult. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936002 ↗
• InjurySep 29, 2026Incomplete Coaptation

  It was reported that a MitraClip procedure was performed to treat functional mitral regurgitation (MR) with a grade of 4. A MitraClip XTW was inserted and deployed on the mitral valve. A second clip was then inserted and advanced to the left ventricle and positioned medial to the first clip. However, it was observed that the clip was too far away. Therefore, the clip was inverted and brought back into the atrium. Once the clip returned to the atrium, it was observed that the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/SLDA). To stabilize the clip, the second clip, The MitraClip XT, was repositioned and deployed on the lateral side of the first clip. To further stabilize the SLDA clip, a third clip was then inserted and deployed on the medial side of the first clip. The procedure was completed with three clips implanted, reducing MR to a grade of 1. It was noted that the patient tolerated the procedure well. There were no adverse patient effects and no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934394 ↗
• MalfunctionSep 29, 2026Crack; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934138 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a MitraClip procedure was performed to treat functional mitral regurgitation (MR) with a grade of 3. A MitraClip XTW (60312A2001) was inserted and deployed on the mitral valve. A second clip, a MitraClip XT (60212A1046) was then inserted and deployed on the mitral valve, reducing MR to trace.On (b)(6) 2026, the patient returned to the hospital with heart failure, which was treated per medical management.On (b)(6) 2026, the patient presented to the hospital. An echocardiogram was performed and revealed a hole in the anterior leaflet and increased MR with a grade of 4+. Both clips were noted to be attached to both leaflets.On (b)(6) 2026 The patient underwent surgery. The patient was reported to be stable and recovering.

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

  MAUDE report 50920386 ↗
• InjurySep 28, 2026Premature Activation; Difficult to Open or Close

  It was reported that a MitraClip procedure was performed to treat functional mitral regurgitation (MR) with a grade of 4-5 on a patient with a small atrium. A steerable guide catheter (SGC) was prepared per the instructions for use (IFU) and successfully crossed the septum. A MitraClip XTW clip delivery system (CDS) was prepared and inserted. However, when the clip was inserted into the left atrium (LA), it was unable to open. Troubleshooting was performed, but the clip was still unable to open. Therefore, a decision was made to remove and replace the clip. However, as the CDS was retracted into the SGC, it appeared unstable; it appeared that it was not well attached to the mandrel, and every movement made, the clip would turn off the mandrel until the clip was perpendicular to the SGC. A snare was then inserted to retrieve the clip. However, the clip was unable to be retrieved, and remained inside the patient, attached to the septum. There was no clinically significant delay in the procedure. The patient was reported to be stable.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 50919991 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50917831 ↗
• InjurySep 28, 2026Positioning Failure; Difficult to Remove; Retraction Problem; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917027 ↗
• InjurySep 25, 2026Incomplete Coaptation

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50899936 ↗
• MalfunctionSep 25, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899619 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
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• Assurity MRI2 models · 17,838 reports · 1 recall
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• Quartet10 models · 11,001 reports
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