PenditureRecalls & reported problems across all models

We found 4 models of Penditure by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between May 9, 2024 and Feb 16, 2026 — classified as 1 death, 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (15 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 Penditure problems

Penditure models

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

• Penditure™ LAAC45

  Left atrial appendage clip, implantable
  7 reports
• Penditure™ LAAC50

  Left atrial appendage clip, implantable
  1 death7 reports
• Penditure™ LAAC40

  Left atrial appendage clip, implantable
  6 reports
• Penditure™ LAAC35

  Left atrial appendage clip, implantable
  2 reports

Recent Penditure adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PENDITURE CLIP FAILED TO STAY ON THE LEFT ATRIAL APPENDAGE DURING THE PROCEDURE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342783 ↗
• InjuryJan 7, 2026Adverse 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 THE CUSTOMER REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION ON (B)(6) 2025. PATIENT WILL BE SEEING E LECTROPHYSIOLOGIST AND HAS RE-STARTED ELIQUIS. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE INVESTIGATOR AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY NOT RELATED TO THE PENDITURE CLIP DEVICE OR THE PENDITURE DELIVERY SYSTEM.

  Patient problems: Atrial Fibrillation

  MAUDE report 23988076 ↗
• InjuryNov 27, 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) 2024, THE CUSTOMER REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHAEMIC ATTACK (TIA) ON (B)(6) 2025, AND IT WAS SUCCESSFULLY TREATED WITH A NEW HOSPITALIZATION (START DATE-(B)(6) 2025, END DATE- (B)(6) 2025). THE ADVERSE EVENT (AE) WAS TREATED WITH AN IMPLANTABLE CARDIAC RHYTHM DEVICE ON (B)(6) 2025 AS THE PATIENT WAS AT RISK FOR A CARDIAC EMBOLIC EVENT. THE DEVICE WAS AN IMPLANTABLE LOOP RECORDER. A CONCOMITANT MEDICATION WAS ADMINISTERED OR ADJUSTED DUE TO THIS AE. DIAGNOSTIC TESTS AND A NEUROLOGICAL EVALUATION WERE PERFORMED. THE NEUROLOGICAL SYMPTOMS RESOLVED WITHIN 24 HOURS. THERE WAS A RAPID ONSET OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT. THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH RIGHT ARM WEAKNESS. AN MRI (MAGNETIC RESONANCE IMAGING) WITH ACUTE TO SUBACUTE STROKE (CVA) IN LEFT POSTERIOR FRONTAL LOBE WAS OBSERVED. THE SYMPTOMS RESOLVED IN 15 MINUTES. THE PATIENT WAS STARTED ON PLAVIX AND CONTINUED ASPIRIN. THEY WERE DISCHARGED HOME. THE NEUROLOGY NOTE AT DISCHARGED STATED THAT AN ATHEROTHROMBOTIC EVENT WAS

  Patient problems: Transient Ischemic Attack

  MAUDE report 23665970 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 3, 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, THE CUSTOMER REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION ON (B)(6) 2025, AND IT WAS TREATED WITH CONCOMITANT MEDICATION ADMINISTERED OR ADJUSTED DUE TO THIS ADVERSE EVENT (AE). THE MEDICATION WAS GIVEN INTRAVENOUSLY. THE AE RESULTED IN THE PROLONGATION OF AN EXISTING HOSPITALIZATION FOR THE SUBJECT. K SHOULDERS HAD HELPED AS WELL. THE PATIENT STATED THAT THEY DID NOT FEEL LIKE THEY COULD MOVE AROUND SUFFICIENTLY BUT THEIR ARMS AND LEGS WORKED SUFFICIENTLY. THE PATIENT WENT INTO ATRIAL FIBRILLATION RAPID VENTRICULAR RESPONSE LAST NIGHT WITH THEIR HEART RATE APPROXIMATELY 170 BPM. THEY WERE STARTED ON AMIO PROTOCOL AND DID CONVERT BACK TO NORMAL SINUS RHYTHM (NSR). THEY REMAINED IN NSR WITH THEIR HEART RATE AT APPROXIMATELY 60 BPM. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING, AND THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2025. THE ADVERSE EVENT WAS DEEMED BY THE INVESTIGATOR AS CASUALLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY

  Patient problems: Atrial Fibrillation

  MAUDE report 21761463 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE DEVICE , IT WAS REPORTED THAT THE CLIP MIGRATED. A 35MM CLIP WAS PLACED WITH NORMAL PRESSURES AND THE LEFT ATRIAL APPENDAGE (LAA) WAS CUT WITH NO BLEEDING - NO INITIAL ISSUES. THE CUSTOMER RE-EVALUATED PENDITURE POST OP CAB BYPASSES AND NOTICED THE CLIP HAD MOVED AT TIP END. THE CUSTOMER REPORTED THERE WAS STILL NO BLEEDING AND NO RECAPTURE DUE TO FACT THAT LAA HAD BEEN CUT FOR DECOMPRESSION. IT WAS LEFT IN PLACE WITH NO FURTHER ECHO EVALUATION. THE CUSTOMER HAD USED AN INFERIOR APPROACH. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS OFF PUMP WHEN THE CLIP WAS PLACED. THE TISSUE WAS OF AVERAGE THICKNESS. IT WAS REPORTED THAT THE CUSTOMER DID NOT USE THE SIZER TO CONFIRM THE CLIP SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206620 ↗
• 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 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE DEVICE, IT WAS REPORTED THAT THE CLIP MIGRATED AND LEAKED AFTER THE CUSTOMER CUT THE APPENDAGE TO TEST. A PLEDGETED SUTURE WAS PLACED TO CONTROL THE LEAK AND 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 20743463 ↗

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