Penditure™ LAAC40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000791452), received between Sep 10, 2024 and Feb 16, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 6 most recent of 6 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 5, 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 THE USE OF THE PENDITURE CLIP ON (B)(6) 2024, THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED CARDIAC RHYTHM SYMPTOMS ON (B)(6) 2024, DESCRIBED AS ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR) AND ASYMPTOMATIC PAUSES. DUE TO THIS ADVERSE EVENT, THE HOSPITALIZATION PERIOD WAS PROLONGED, LASTING FROM (B)(6) 2024. INTRAVENOUS TREATMENT WITH CONCOMITANT MEDICATION, INCLUDING CLASS III ANTIARRHYTHMICS, ANTICOAGULANTS, AND OTHER ANTIPLATELETS, WAS INITIATED ON (B)(6) 2024 AND IS STILL ONGOING. THE ADVERSE EVENT WAS DEEMED BY BOTH THE SITE AND THE SPONSOR AS POSSIBLY RELATED TO THE CLIP AND AS NOT RELATED TO THE PENDITURE DE LIVERY SYSTEM DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 20608519 ↗
• InjurySep 10, 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 THE PATIENT HAD ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE WITH INTERMITTENT SUPRAVENTRICULAR TACHYCARDIA ON (B)(6) 2024, AND WAS SUCCESSFULLY TREATED FIRSTLY WITH ANTICOGUALNTS (START DATE-UNKNOWN -2021, END DATE- (B)(6) 2024), ASPIRIN (START DATE-(B)(6) 2024, END DATE- ONGOING) , ANTICOAGULANT (START DATE-(B)(6) 2024, END DATE- ONGOING), CLASS III ANTIARRHYTHMICS (START DATE-(B)(6) 2024, END DATE- ONGOING). THE PATIENT HAS HISTORY OF ATRIAL FIBRILLATION, AND IT WORSENED WHILE INPATIENT FOLLOWING PROCEDURE. AMIODARONE IV DRIP STARTED. THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF ELECTROCARDIOGRAM ON (B)(6) 2024. THIS RESULTED IN ATRIAL FIBRILLATION WITH ABERRANT VENTRICULAR BEATS. THIS WAS CLINICALLY SIGNIFICANT. BLOOD TEST CARIED OUT ON (B)(6) 2024, AND THE RESULT STATES: STAT ELECTROLYTES SENT -CLINICALLY SIGNIFICANT: NO. THE OUTCOME IS UNKNOWN, AND THE PATIENT HAVE BEEN HOSPITALIZED SINCE (B)(6) 2024 THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE PENDITURE CLIP DEV

  Patient problems: Atrial Fibrillation

  MAUDE report 20179216 ↗