Penditure™ LAAC35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000791445), received between Jan 22, 2025 and Jan 7, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗