MitraClip™ CDS0801-XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 05415067050762), received between Jun 16, 2025 and Sep 30, 2026 — classified as 3 deaths, 51 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (42 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 115 reports, 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 ↗
• MalfunctionSep 29, 2026Difficult to Open or Close; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940086 ↗
• 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 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 ↗
• MalfunctionSep 25, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899619 ↗
• InjurySep 25, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026 a patient presented with grade 4+ functional mitral regurgitation (MR), rotated heart and restricted anterior leaflet for a Mitraclip procedure. During the procedure, mitraclip was implanted. After deployment, it was determined that there was a single leaflet device attachment (SLDA) and the clip was no longer attached to the anterior leaflet. Additional clip was implanted to stabilize the SLDA. Imaging was difficult. 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 50899578 ↗
• InjurySep 21, 2026Difficult or Delayed Positioning; Entrapment of Device

  It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (MR) and small flail for a MitraClip procedure. During the procedure, MitraClip NT anterior gripper was unable to lower during grasping of the leaflets. Difficulty was encountered while capturing the leaflets due to sub-optimal imaging. Troubleshooting was performed and was unsuccessful. Multiple grasping and capturing attempts contributed to leaflet damage. The MitraClip was removed from the anatomy.MitraClip XT was inserted into the anatomy. Additional chordal rupture was observed in the grasping area due to the chordal entanglement. Troubleshooting was performed and was unsuccessful in disengaging the clip from chordae. As a result, the MitraClip XT was implanted on anterior leaflet and chordae. The MR remained unchanged post procedure. There was no clinically significant delay reported.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 50845796 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (MR), thin friable tissue for a Mitraclip procedure. During the procedure, two MitraClip XT were implanted. During implantation of a third MitraClip XT, multiple grasps were made on the friable tissue. A leaflet tear was then observed. The third clip was removed from the patient and replaced with a MitraClip NT. The third clip was implanted. The final MR remained at grade 4.On (b)(6) 2026 the patient presented with heart failure with a v wave of 70mmHg. A balloon pump was inserted but did not resolve symptoms. The patient passed away. The clips remained stable at the time of death. The physician believed the tissue injury was due to the MitraClip and overall tissue integrity.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50500664 ↗
• DeathAug 26, 2026Expulsion

  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 thin and friable posterior mitral leaflet, a suspected leaflet cleft at the origin of the MR jet, and a patient who was considered to be high risk for MitraClip procedure. A MitraClip XT was inserted and deployed on the mitral valve. However, post deployment, the clip detached from both leaflets (expulsion) and embolized, and attached to chordae only. It was noted that tissue damage was observed. In the physician¿s opinion, the clip embolized due to poor posterior leaflet integrity. An attempt was made to retrieve the clip but was not successful. Therefore, the clip remained where it was stuck, attached to chordae only, and the procedure was discontinued. The MR remained unchanged. There was clinically significant delay in the procedure due to the tissue injury and clip remaining attached to chordae. It was noted that the patient remained hemodynamically stable throughout the procedure The patient was then transferred to non-intensive care unit (ICU) status, and hospitalized.On an unknown date, the patient was reported to have

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

  MAUDE report 50461319 ↗
• DeathAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with grade 3+ mixed mitral regurgitation (MR), prolapsed posterior leaflet, coaptation gap of nearly 10 mm and enlarged atrium for a Mitraclip procedure. The initial screening MR grade 3+ but worsened to 4+ at the start of the procedure. The cause was unknown. During the procedure, the MitraClip XTW was implanted. The decision was made to implant a second MitraClip XT. Grasping was attempted and after a few grasping attempts, it was observed that there was a torn anterior leaflet. The second MitraClip XT was removed from the patient. The first clip remained stable. The final MR was grade 4+. The following day, the patient went into shock and passed away. The patient's family declined additional intervention and medical therapy. The physician believed worsening heart failure and significantly severe MR prior to the procedure, in addition to the torn tissue likely contributed to the death.

  Patient problems: Shock; Unspecified Tissue Injury

  MAUDE report 50326466 ↗
• InjuryAug 6, 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 leaflet for a MitraClip procedure. During the procedure, a MitraClip was implanted.During deployment sequence of second clip, the posterior leaflet was partially tore while grasping the leaflet. However, the clip was deployed successfully. The MR was reduced to grade 3-4 post procedure. There was no clinically significant delay reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50164531 ↗
• InjuryAug 6, 2026Entrapment of Device

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR) and a prolapsed posterior leaflet for a MitraClip procedure. During the procedure, a MitraClip was successfully placed on the leaflets. The mean pressure gradient (MPG) increased to 5mmHg. A second MitraClip was then advanced within the patient and placed on the leaflets. The mean pressure gradient increased to 9 mmHg. While removing the clip from the leaflet, it became caught on the anterior leaflet. Troubleshooting was performed unsuccessfully. The clip was able to regrasp the posterior leaflet and was successfully implanted. The procedure was discontinued, the final MR was grade 1 and the MPG was 8mmHg. There were no clinically significant delays reported.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 50161939 ↗
• InjuryAug 3, 2026Entrapment of Device

  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, a MitraClip XT, was then prepared for use and inserted. However, during placement of the second clip, the clip dove slightly lateral. It was suggested to correct the clip by applying the M knob. However, the physician decided to open the clip first and then move the clip, which resulted in the clip becoming caught on anatomy. Troubleshooting was performed. It was noted that removing M knob did not result in the clip moving due to the chordal interaction. However, the clip was unable to be removed. Although the clip became caught in chordae, it was able to grasp both leaflets. The second clip was then repositioned closer to the first clip, the leaflets were able to be grasped, and the clip was deployed on the mitral valve. It was noted that both clips were attached to both leaflets, with chordae. The clip was stable on the leaflets. The procedure was completed, and the MR was reduced to a grade of 1. There was no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122628 ↗
• InjuryJul 31, 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), flail, prolapsed posterior and anterior leaflet for a Mitraclip procedure. During the procedure, first and second mitraclips was implanted and physician decided to implant third mitraclip to further reduce the MR. When attempting to grasp the leaflet with the third clip, it was noted that there was possible perforation of the posterior leaflet. Third clip was implanted. The final MR was grade 4. There were no adverse patient effects or clinically significant delays reported.

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

  MAUDE report 50098840 ↗
• InjuryJul 27, 2026Positioning Failure

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR) for a Mitraclip procedure. During the procedure, first mitraclip XTW was implanted on central side of anterior and posterior 2 (A2/P2). Mitraclip XT was inserted and grasping was attempted, when closing the clip, the anterior mitral leaflet slipped out. Grasping was achieved and the gradient was 6 mmHg and patient had pulmonary hypertension. Decision was made to remove the clip. It was noted that lateral jet was worse. It was noted that anterior mitral leaflet was damaged. Physician decided to implant mitraclip NT. The final MR was grade 1-2. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: High Blood Pressure/ Hypertension; Unspecified Tissue Injury

  MAUDE report 50042632 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a second MitraClip procedure was performed to treat degenerative mitral regurgitation (MR) with a grade of 4 and a mean pressure gradient of 3mmHg on a patient with a prolapsed posterior leaflet, diseased leaflet with a calcium shelf below the leaflet on the chords and previously implanted MitraClip. A MitraClip XT was inserted, and grasping was performed medial to the first implanted clip. However, upon closing the clip, the posterior leaflet was observed to be perforated. It was noted that the orientation was off, and there was a significant jet medial to the grasp. The clip was then repositioned to grasp the medial jet, and grasping was performed. However, the pressure gradient increased to 11mmHg. The leaflets were ungrasped, the pressure gradient returned to baseline, and the clip was removed from the patient. No clips were implanted during the procedure. The procedure was discontinued. There was no clinically significant delay in the procedure.

  Patient problems: Mitral Valve Stenosis; Unspecified Tissue Injury

  MAUDE report 50018613 ↗
• InjuryJul 1, 2026Unintended Movement

  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, WHILE DEPLOYING THE CLIP, CLIP OPENED. ANOTHER MITRACLIP XT WAS IMPLANTED TO STABILIZE THE FIRST CLIP. IMAGING WAS DIFFICULT. 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 25682863 ↗
• InjuryJun 26, 2026Positioning Failure; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), PROMINENT CHORDAE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED ON THE CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2). IT WAS DECIDED TO PLACE THE SECOND CLIP. CLIP WAS INSERTED, ADVANCED AND LEAFLETS WERE GRASPED. CLIP WAS LOCKED AND CLOSED. IMAGER WAS CONCERNED WITH ANTERIOR MITRAL LEAFLET INSERTION AND INTERACTION WITH SECONDARY CHORDAE. ANTERIOR MITRAL LEAFLET INSERTION WAS CHECKED. CLIP WAS UNLOCKED, OPENED WITH GRIPPERS DOWN AND IT WAS OBSERVED THAT THERE WAS SOME BOUNCE. GRIPPER WAS RAISED AND LEAFLET WAS ON BUT WAS NOT CONVINCED. CLIP WAS SWUNG ANTERIORLY AND RETRACTED UP. CLIP WAS SHIFTED TOWARDS SECONDARY CHORDAE AND THE GRIPPER WAS LOWERED. STEERABLE GUIDE CATHETER WAS PLACED BACK TO THE NEUTRAL POSITION. PHYSICIAN HAD A DOUBT OF CLOT. HOWEVER, ON EVALUATION IT WAS OBSERVED THAT THE MR WORSENED AND THE APPEARED TO HAVE FLAIL WITH CHORDAE. IT WAS DECIDED TO REMOVE THE CLIP. MITRACLIP XTW WAS OPENED AND WAS IMPLANTED. THE FINAL MR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25637209 ↗
• MalfunctionJun 12, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, CLIP WAS INSERTED AND STEERED DOWN TO THE MITRAL VALVE. UPON TESTING THE GRIPPERS, IT WAS NOTED THAT POSTERIOR GRIPPER WOULD NOT LOWER. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. DEVICE WAS REMOVED FROM THE PATIENT AND WAS REPLACED. 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 25491565 ↗
• MalfunctionJun 12, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, UPON TURNING THE M KNOB, THE SLEEVE SHOWCASED UNINTENDED MOVEMENT. THE CLIP WAS REMOVED FROM THE ANATOMY. THE SAME ISSUE WAS OBSERVED IN THREE MORE CLIPS. HOWEVER, THE THREE CLIPS WERE DEPLOYED SUCCESSFULLY. THE MR WAS REDUCED TO GRADE 3-4 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485356 ↗
• MalfunctionJun 12, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, UPON TURNING THE M KNOB, THE SLEEVE SHOWCASED UNINTENDED MOVEMENT. THE CLIP WAS REMOVED FROM THE ANATOMY. THE SAME ISSUE WAS OBSERVED IN THREE MORE CLIPS. HOWEVER, THE THREE CLIPS WERE DEPLOYED SUCCESSFULLY. THE MR WAS REDUCED TO GRADE 3-4 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485355 ↗
• MalfunctionJun 5, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND DENSE CHORDAE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, LOCK TEST WAS FAILED AFTER INITIAL GRASP. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. CLIP WAS REMOVED FROM THE PATIENT AND WAS PROCEEDED WITH PLACING TWO MITRACLIP NT. 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 25414508 ↗
• MalfunctionMay 29, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4 ON A PATIENT WITH A PROLAPSED ANTERIOR LEAFLET, PROLAPSED POSTERIOR LEAFLET, THICK LEAFLETS, AND ENLARGED ATRIUM WITH AORTIC HUGGER. A MITRACLIP XT WAS INSERTED AND PLACED ON THE MITRAL VALVE. HOWEVER, WHILE ATTEMPTING TO DEPLOY THE CLIP, DIFFICULTIES DETACHING THE CLIP FROM THE CLIP DELIVERY SYSTEM (CDS) OCCURRED. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO DETACH FROM CDS, AND WAS ULTIMATELY DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333819 ↗
• MalfunctionMay 21, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, 3 MITRACLIPS WERE IMPLANTED SUCCESSFULLY. POST PROCEDURE, ECHOCARDIOGRAPHY REVEALED THAT THE THIRD CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE ANTERIOR LEAFLET. THE MR WAS REDUCED TO GRADE 2+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240792 ↗
• InjuryMay 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY PLACED ON THE LEAFLETS. AFTER GRASPING THE LEAFLETS, THE CLIP WAS UNABLE TO BE UNLOCKED. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND THE CLIP WAS IMPLANTED. A SECONDARY MITRACLIP WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS DISCONTINUED; THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232087 ↗