Penditure™ LAAC50Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000791476), received between Jul 26, 2024 and Aug 13, 2025 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PENDITURE CLIP, THE CASE WAS A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND THE CLIP SLIPPED DURING THE OPERATION, AND A HUGE STUMP WAS OBSERVED ON ECHOCARDIOGRAM. THE CLIP HAD TO BE REPOSITIONED CLOSER TO THE BASE. AN ECHOCARDIOGRAM WAS PERFORMED BEFORE COMING OFF THE PROCEDURE AND AFTER REPOSITIONING, WHICH SHOWED THAT THE REPOSITION LOOKED GOOD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792294 ↗
• DeathMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE CLIP ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD DIED ON (B)(6) 2025. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CLIP AND AS NOT RELATED TO THE PENDITURE DELIVERY SYSTEM DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21603110 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF APPENDITURE DEVICE, IT WAS REPORTED THAT THE PATIENT HAD AN ELEVATED PULMONARY ARTERY (PA) PRESSURE OF 70/38 AND THICKENED LEFT ATRIAL APPENDAGE (LAA). THE CLIP WAS PLACED WITH AN INFERIOR APPROACH AND IMMEDIATELY MOVED AFTER RELEASE AT THE U END OF THE DEVICE, THE TIP END STAYED IN PLACE. IT WAS RECAPTURED TWO MORE TIMES AND RELEASED WITH SIMILAR RESULTS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT CUSTOMER DID NOT USE A SIZER AND NEVER HAD FOR ANY APPENDAGE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262971 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE LAA EXCLUSION SYSTEM, THE DEVICE MOVED AFTER SUBOPTIMAL DEVICE PLACEMENT; THE SURGEON USED AN INFERIOR APPROACH TO ACCESS AND PLACE THE DEVICE ONTO THE APPENDAGE AND IT LOOKED LIKE A GOOD PLACEMENT. THE CURVED TIP WAS POINTING TOWARD THE ATRIUM. THEN THE REST OF THE PROCEDURE TOOK PLACE. AT THE END OF THE PROCEDURE, THE ANESTHESIOLOGIST SAW FLOW AND ASKED THE SURGEON IF THE CLIP WAS DEPLOYED. WHEN CHECKING THE ECHO, THEY NOTICED THAT THE CLIP HAD SLIPPED ABOUT HALFWAY DOWN THE APPENDAGE. THE SURGEON RECAPTURED THE DEVICE AND PLACED IT AGAIN IN AN APPROPRIATE MANNER. THE CLIP MOVED AGAIN (IT WAS PLACED IN ONE AREA, AND IT ENDED UP IN ANOTHER PLACE). THE SURGEON ASKED FOR, AND PLACED, A COMPETITOR¿S CLIP (USING THE SAME SIZE) WITH NO ISSUES. THE SURGEON COMMENTED THAT THE PROCEDURE WAS A REDO AND THAT THE PATIENT HAD PERICARDITIS, WHICH MAY HAVE AFFECTED THE PERFORMANCE OF THE CLIP. THE ESTIMATED TOTAL NUMBER OF ACTUATIONS WAS 3 TIMES AND RECAPTURE 1 TIME. A SIZER WAS USED TO DETERMINE THE CORRECT SIZE OF THE DEVICE. THE DEVICE WAS REPLACED PRIOR TO CLOSURE OF THE PATIENT. IT WAS REPORTED THAT THE OPERATING ROOM TIME WAS I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262890 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE DEVICE, THE CUSTOMER REPORTED A LEAK AT THE U PORTION OF THE CLIP. THE LEFT ATRIAL APPENDAGE (LAA) CLIP LEAKED AND MIGRATED AROUND. THE CUSTOMER CLAIMS THAT THE LARGER CLIPS MAY NOT HAVE ENOUGH CLOSURE FORCE. THE CUSTOMER PUT A PLEDGETED SUTURE TO CONTROL THE LEAK AFTER CUTTING THE APPENDAGE TO TEST AND ALSO USED THE PLEDGET TO STOP MIGRATION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20742746 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE CLIP ON (B)(6) 2024, THE CUSTOMER REPORTED THAT THE PATIENT HAD A COMPLETE HEART BLOCK. THE PATIENT WAS PRESENTING WITH ASYMPTOMATIC COMPLETE HEART BLOCK WITH JUNCTIONAL ESCAPE RHYTHM. THEY WERE ADMITTED ON (B)(6) 2024 FOR A PERMANENT PACEMAKER (PPM) IMPLANT. THEY WERE SUBJECT TO A NEW HOSPITALIZATION. ON (B)(6) 2024, THEY WERE SUCCESSFULLY TREATED WITH AN IMPLANTABLE CARDIAC RHYTHM DEVICE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS NOT RELATED TO THE PENDITURE DELIVERY SYSTEM DEVICE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE CLIP AND AS NOT RELATED TO THE PENDITURE DELIVERY SYSTEM DEVICE. THE END DATE OF THE HOSPITALIZATION WAS (B)(6) 2024. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING WITH SEQUELAE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE IMPLANT PROCEDURE REQUIRED THE ADMINISTRATION OF IV ANTIBIOTICS FOR PROPHYLAXIS PURPOSES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SPONSOR HAS DEEMED THE ADVERSE EVENT AS NOT RELATED TO THE PENDITURE CLIP OR DELIVERY SYSTEM.

  Patient problems: Heart Block

  MAUDE report 20556001 ↗
• MalfunctionJul 26, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE, IT WAS REPORTED THAT THE CLIP WAS MIGRATING AND SLIPPING AT THE BASE END. THE CUSTOMER REMOVED THE CLIP. THE LEFT APPENDAGE WAS LEFT WITHOUT A CLIP. THEY DID NOT END UP USING ANOTHER CLIP ON THIS PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT USE THE SIZER TO CONFIRM THE CLIP SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836810 ↗