Penditure™ LAAC45Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000791469), received between May 9, 2024 and Aug 28, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER SIZING, DURING USE OF A PENDITURE DEVICE, THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES DURING THE OPERATION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE APPLIED CLIP EXTENDED SLIGHTLY DISTALLY TOWARD THE LEFT ATRIAL APPENDAGE. WHILE THE PATIENT'S POSTOPERATIVE CONDITION SHOWED NO ISSUES, THERE WAS A CONCERN RAISED ABOUT POTENTIAL COMPRESSION OF THE LEFT MAIN CORONARY ARTERY. IT WAS COMMUNICATED THAT FURTHER EXAMINATIONS, SUCH AS A CT SCAN, WOULD BE CONDUCTED. DEPENDING ON THE RESULTS OF THE EXAMINATION, THORACOTOMY AGAIN MAY BE PERFORMED TO RECAPTURE THE CLIP AND REPOSITION IT AS NECESSARY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS A PVI (PULMONARY VEIN ISOLATION). THE DEVICE WAS DEPLOYED ON A BEATING HEART. THE IMPLANT TECHNIQUE WAS THE LEFT ATRIAL APPENDAGE CLOSURE VIA THE INFERIOR APPROACH. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911038 ↗
• InjuryAug 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER SURGERY THE PENDITURE CLIP, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED SEVERAL DAYS LATER AND IT WAS OBSERVED THAT THE CLIP HAD SLIPPED OFF, RESULTING IN A 2CM RESIDUAL STUMP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS AN AORTIC VALVE REPLACEMENT (AVR), IN COMBINATION WITH CORONARY ARTERY BYPASS GRAFT (CABG) X3. THE CLIP WAS NOT DEPLOYED ON A BEATING HEART. A SIZER WAS USED TO DETERMINE THE CLIP SIZE. THE IMPLANT TECHNIQUE WAS FULL STERNOTOMY AND THE SITE OF INSERTION WAS AN ARRESTED HEART. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE. THE PATIENT RETURNED TO THE HOSPITAL WITH RAPID ATRIAL FIBRILLATION. A PRE-CARDIOVERSION TEE SHOWED A 2CM RESIDUAL LEFT ATRIAL APPENDAGE (LAA). ANTICOAGULATION WILL HAVE TO BE CONTINUED.

  Patient problems: Atrial Fibrillation

  MAUDE report 22883433 ↗
• MalfunctionJul 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE PENDITURE DEVICE, THE SURGEON FELT THE CLIP WAS SLIPPING OFF THE PROXIMAL END. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539998 ↗
• MalfunctionFeb 19, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE CLIP DEVICE, AT THE END OF THE PROCEDURE, PRIOR TO COMING OFF BYPASS, THE CUSTOMER MEASURED AND PLACED THE PENDITURE DEVICE ACROSS THE LEFT ATRIAL APPENDAGE. THE CUSTOMER NOTED THAT IT WAS DIFFICULT TO OBSERVE THE ENTIRE APPENDAGE. THE CUSTOMER ASKED THE PERFUSION TO FILL THE HEART AND FOR THE ANESTHESIOLOGIST TO VERIFY THAT THEY HAD COMPLETE CLOSURE OF THE LEFT ARTRIAL APPENDAGE (LAA) ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE ANESTHESIOLOGIST NOTED THAT THERE WAS A SMALL AREA DISTALLY THAT HAD BLOOD FLOW AND SUGGESTED TO THEM TO RECAPTURE AND REDEPLOY THE DEVICE. THE CUSTOMER TRIED TO RECAPTURE THE DEVICE BY INSERTING A LONG PRONG OF THE HANDLE INTO THE CLIP THAT WAS ATTACHED TO THE APPENDAGE. THEY STATED THAT THE PRONG WAS STUCK IN THE CLIP AND WOULD NOT ALLOW HIM TO ADVANCE OR PULL OUT. THE CUSTOMER CONTINUED TO MANIPULATE THE HANDLE WITH THE PRONG STUCK AND NOTED THAT BLEEDING WAS COMING FROM APPENDAGE. THEY REQUESTED FOR A COMPETITIVE CLIP TO BE OPENED AND PLACED THE COMPETITIVE DEVICE ACROSS THE APPENDAGE. THE TEE REVEALED THAT THERE WAS STILL A SMALL AMOUNT OF BLOOD FLOW ACROSS THE APPENDAGE. THERE WAS NO A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414590 ↗
• MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE DEVICE, THE CUSTOMER REPORTED THAT THE CLIP WAS DEPLOYED, RECAPTURED AND EXPERIENCED SLIPPING. IT WAS RECAPTURED AGAIN AND DEPLOYED. IT WAS CONFIRMED WITH A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND WAS 0.3MM WITH NO FLOW. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A SIZER WAS USED TO CONFIRM THE CLIP SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206371 ↗
• InjuryJun 13, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE LAA, IT WAS REPORTED THAT THE DEVICE WAS NOT OCCLUSIVE ENOUGH FOR THE CUSTOMER. THE CUSTOMER STATED THAT THE FA HOLDING THE APPENDAGE WHILE THEY PLACED THE CLIP, ACCIDENTALLY TORE THE TIP OF THE APPENDAGE, SO THERE WAS BLEEDING. THE CUSTOMER PLACED THE CLIP AND THE BLEEDING CONTINUED FROM THE APPENDAGE TEAR. THE CUSTOMER WAS SURPRISED THAT THE TEAR CONTINUED TO BLEED AND THEY BELIEVED THAT THE BLEEDING WOULD STOP FROM THE COMPRESSION FORCE OF THE CLIP. THE BLEED DID NOT STOP, THEREFORE, THEY REPOSITIONED THE CLIP. THE BLEEDING CONTINUED AFTER REDEPLOYMENT. THE CUSTOMER STATED THAT THE CLIP WAS DIFFICULT TO REMOVE FROM THE DELIVERY TOOL. IT WAS NECESSARY FOR THE CUSTOMER TO HOLD THE CLIP IN POSITION AND TO CREATE A COUNTER FORCE IN THE OPPOSITE DIRECTION OF THE REMOVAL OF THE DELIVERY TOOL TO GET THE CLIP OFF THE DEVICE. THEY TESTED THE REMOVAL OF THE CLIP AGAIN, OFF THE HEART, AND THEY NOTICED THAT THE SAME STICKINESS OF REMOVING THE CLIP FROM THE TOOL. THERE WAS A SLIGHT DELAY IN PROCEDURE. THE CUSTOMER BELIEVED THAT THEY HELD THE BLUE TRIGGER BUTTON DOWN THE WHOLE TIME WHILE REMOVING THE CLIP FROM THE TOOL. THE DEVICE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19526969 ↗
• InjuryMay 9, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF APPENDITURE LAA, IT WAS REPORTED THAT THE PATIENT HAD POST OPERATIVE BLEEDING AND IT WAS DEEMED NECESSARY TO OPEN THE PATIENT BACK UP TO FIND THE SOURCE. THE CUSTOMER REALIZED IT WAS LOCATED WHERE THE HOLES FOR RECAPTURE ARE LOCATED ON THE PENDITURE CLIP. THE PLACEMENT OF THE DEVICE ORIGINALLY WAS SUCCESSFUL AND THE CUSTOMER WAS SATISFIED. THE CLIP WAS PLACED AT APPROXIMATELY 2:00PM. THE APPENDAGE WAS EXCLUDED AND THEY CONTINUED TO THE NEXT PART OF THE PROCEDURE. THE PATIENT WAS RETURNED BACK TO THE OPERATIVE ROOM AT AROUND 7:00PM. THE PATIENT'S CHEST WAS REOPENED. SEE ATTACHED PHOTOS/VIDEO. THE CUSTOMER WAS GOING TO REMOVE THE CLIP AS THEY WERE NOT SURE WHAT CAUSED THE ISSUE ORIGINALLY. HOWEVER, THE CUSTOMER DECIDED TO LEAVE THE CLIP ON. THE CUSTOMER OBSERVED THAT THE PROXIMAL END OF THE PENDITURE CLIP, WHERE THE HOLD FOR THE RECAPTURE ARE LOCATED, WAS RUBBING AGAINST THE HEART TISSUE AND CAUSED A HOLE. AS A RESULT, THE HOLE CAUSED A LEAKAGE OF BLOOD. THE CUSTOMER PROCEEDED TO PLACE TWO SUTURES WITH PLEDGETS IN THE LOCATION OF THE BLEEDING. THE CUSTOMER FIXED THE ISSUE BY PLACING THE TWO SUTURES. THE CUSTOMER DID N OT WANT TO RE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 19278039 ↗