MitraClip™ CDS0801-XTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 05415067050779), received between Jun 12, 2025 and Sep 30, 2026 — classified as 5 deaths, 132 injuries, 198 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (109 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 335 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 23, 2026Migration

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50874487 ↗
• MalfunctionSep 23, 2026Difficult to Open or Close

  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, after the grasping the leaflets the MitraClip XTW was unable to open. Troubleshooting was performed and was unsuccessful. As a result, the clip was implanted in it's existing position. Additional MitraClip was implanted to treat the residual jet. The MR was reduced to grade 1-2 post procedure. There was no clinically significant delay or adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873129 ↗
• MalfunctionSep 23, 2026Device Damaged by Another Device

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (MR), pre-existing chordal rupture, restricted and flail posterior leaflet for a MitraClip procedure. During the procedure, first MitraClip XTW implanted on anterior -posterior commissure.Post deployment, posterior leaflet was observed to be ruptured. Second MitraClip XTW was implanted lateral to first MitraClip.The first MitraClip XTW had single leaflet device attachment (SLDA) from the posterior leaflet due to interaction between two clips. The MR was reduced to grade 3+ post procedure. There was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871218 ↗
• InjurySep 23, 2026Incomplete Coaptation; Device Damaged by Another Device

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (MR), pre-existing chordal rupture, restricted and flail posterior leaflet for a MitraClip procedure. During the procedure, first MitraClip XTW implanted on anterior -posterior commissure.Post deployment, posterior leaflet was observed to be ruptured. Second MitraClip XTW was implanted lateral to first MitraClip.The first MitraClip XTW had single leaflet device attachment (SLDA) from the posterior leaflet due to interaction between two clips. The MR was reduced to grade 3+ post procedure. There was no clinically significant delay reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50871163 ↗
• InjurySep 23, 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) and restricted anterior and posterior leaflet for a MitraClip procedure. During the procedure, the Clip Delivery System (CDS) was retracted to facilitate leaflet grasping. At that time, the patient experienced cardiac arrest. Cardiopulmonary resuscitation (CPR) was initiated and performed to treat the event. Subsequently, complete heart block was observed, and transcutaneous pacing was performed. A temporary transvenous pacemaker was then inserted, and the patient was stabilized.Following stabilization, the procedure was continued with MitraClip deployment. Post-procedure, the MR was reduced to grade 1-2. No clinically significant procedural delay was reported.

  Patient problems: Cardiac Arrest; Heart Block

  MAUDE report 50870849 ↗
• DeathSep 17, 2026Difficult or Delayed Positioning

  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, mitral valve height was 3.25 to 3.5 centimeters. Physician decided to proceed with this height. Once the clip was in position, physician unstraddled the guide to gain the height. This move has caused tear in the anterior leaflet. IntraAortic balloon pump was inserted but was unable to insert due to the small size of the vessel. Procedure was discontinued. All steps were performed as per IFU. Imaging was difficult. The final MR was grade 4. On (b)(6) 2026, it was reported that patient passed away.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50808280 ↗
• InjurySep 16, 2026Entrapment of Device; Expulsion

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (MR), flail anterior leaflet, prolapsed posterior leaflet for a MitraClip procedure. During the procedure, difficulty was encountered in adequate leaflet insertion due to sub-optimal imaging and presence of tissue.After a couple of grasping attempts, the MitraClip XTW was deployed on both the leaflets along with tissue. Post deployment, MitraClip XTW was observed to be mobile and partially detached from the anterior leaflet. Second MitraClip was implanted laterally to first Clip. The MR was reduced to grade 2-3 post procedure.On (b)(6) 2026, the patient returned symptomatic with recurrent MR of grade 3. Transesophageal echocardiogram (TEE) revealed embolization of MitraClip XTW. The patient was reported to be clinically stable. There was no clinically significant delay reported.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50793347 ↗
• MalfunctionSep 14, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762949 ↗
• MalfunctionSep 14, 2026Difficult to Open or Close

  It was reported that a MitraClip procedure was performed to treat degenerative mitral regurgitation (MR) with a grade of 4 on a patient with a prolapsed posterior leaflet and pre-existing flail. A MitraClip XTW was inserted and deployed on the mitral valve. A second MitraClip XTW (60422R1004) was then prepared for use. However, while preparing the second MitraClip XTW, after testing the lock sequence, the clip would not open. Troubleshooting was performed but was not successful. Therefore, the clip was not used. The procedure was completed with one clip implanted, reducing MR to a grade of 1. There were no adverse patient effects and no clinically significant delay in the procedure.Device returned and analysis performed on (b)(6)2026 revealed that the mandrel was protruding from the proximal end of the actuator knob, the collet was broken, and there was a leak at the handle-arm positioner.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756712 ↗
• InjurySep 9, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026, a MitraClip procedure was performed to treat mixed mitral regurgitation (MR) with a grade of 4 on a patient with a restricted posterior mitral leaflet (PML) and an anterior leaflet overriding PML. A first clip, a MitrClip XTW (60123A1033) was inserted and deployed on the mitral valve. A second clip, a MitraClip NTW (50915A1041) was inserted and deployed on the mitral valve, reducing MR to trace.On (b)(6) 2026, during pre-procedural imaging for a TriClip procedure, it was observed that the previously implanted MitraClip XTW (60123A1033) 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 3. On extensive interrogation, it was determined that there were likely some chordae in the clip without full posterior leaflet insertion. The TriClip procedure was then completed successfully. No additional information was provided.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50693697 ↗
• InjurySep 4, 2026Incomplete Coaptation

  It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (MR), thick and flail leaflet for a MitraClip procedure. During the procedure, a MitraClip XTW was successfully implanted. The MR was reduced to grade 1 post procedure. On (b)(6) 2026, follow up revealed the clip had single leaflet device attachment (SLDA) from the anterior leaflet. Recurrent MR of grade 3 was reported. There was no clinically significant delay reported.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50617420 ↗
• MalfunctionSep 4, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615726 ↗
• InjuryAug 27, 2026Incomplete Coaptation

  It was reported on (b)(6) 2026 that the patient presented with grade 4 functional mitral regurgitation (MR) and restricted posterior leaflet for a MitraClip procedure. During the procedure, a MitraClip was successfully implanted. The MR was reduced to grade <1 post procedure.Approximately after 2 months of deployment, the MitraClip XTW had single leaflet device attachment (SLDA) from the posterior leaflet. Recurrent MR of grade 3 was reported along with dyspnea.On (b)(6) 2026, a re-interventional procedure was performed. Additional 2 MitraClips were implanted to stabilize the SLDA clip. The MR was reduced to grade 1-2 post procedure. There was no clinically significant delay reported.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50474443 ↗
• DeathAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with degenerative mitral regurgitation (MR) and an Anterior 2/3 leaflet flail for a MitraClip procedure. During the procedure, a MitraClip was successfully implanted on the anterior-3/posterior-3 (A3/P3) leaflets. The patient went into cardiogenic shock, a balloon pump was successfully placed and the patient was stabilized. During preparation of the second MitraClip, it was identified during the lock check that the clip would not open. Troubleshooting was performed unsuccessfully. The procedure was discontinued, the final MR was reduced. The patient was admitted to the hospital for monitoring. There were no clinically significant delays reported.It was reported that during the following weekend, (b)(6) 2026, the patient was declared dead while in the ICU. No additional information was provided.

  Patient problems: Cardiogenic Shock

  MAUDE report 50461489 ↗
• MalfunctionAug 17, 2026Unintended Movement

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (MR), restricted posterior leaflet for a Mitraclip procedure. During the procedure, clip opened 2 times after lockline removal. Troubleshooting was performed and clip was deployed. Clip opened after deployment. It was noted that clip angle was 5-10 degrees before opening and approximately 30 degrees after opening. 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 50282749 ↗
• InjuryAug 17, 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), thick and flail leaflet for a Mitraclip procedure. During the procedure, while deploying the clip, patient had hypotension, bradycardia and heart block. Epinephrine is given to the patient. The final MR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Bradycardia; Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 50282746 ↗
• InjuryAug 17, 2026Entrapment of Device; Difficult to Open or Close

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR), restricted anterior leaflet for a Mitraclip procedure. During the procedure, mitraclip XTW would not open. Troubleshooting was performed but was unsuccessful. Clip was caught on the atrial side of the anterior leaflet and damage was noted and clip was implanted on only anterior leaflet. Device was replaced and continued the procedure. All steps were performed as per IFU. The final MR was grade 3+. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 50282379 ↗