Tri-Staple 2.0 SIG45AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521808959), received between Apr 11, 2022 and Sep 28, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50925364 ↗
• MalfunctionSep 23, 2026Retraction Problem; Insufficient Device Problem Information

  It was reported that during a robotic laparoscopic lung wedge resection, when the reload was applied to transect the lung, the cartridge was completely fired but would not open and had difficulty retracting to the knife blade. The handle was removed during troubleshooting; however, the cartridge remained locked on the lung tissue, and the proximal end of the cartridge shaft broke off. Moreover, the handle cracked. To resolve the issue, the cartridge was resected from the lung for removal, and the tissue was re-stapled. The surgical case was extended by approximately one hour. Medtronic's initial evaluation of the incident device found incomplete retraction condition.

  Patient problems: Insufficient Information

  MAUDE report 50871409 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455737 ↗
• MalfunctionMay 21, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LUNG RESECTION, AT THE TIME OF LUNG TISSUE RESECTION, THE RELOAD ARTICULATION JOINT BROKE. THE RELOAD WAS CUT OFF OF THE LUNG TISSUE USING ANOTHER STAPLER TO FREE IT. ADDITIONAL LUNG CAPACITY WAS SACRIFICED DUE TO THE EXTRA CUT NEEDED TO FREE THE STAPLE. ADDITIONAL RESECTION AND RE-STAPLING WAS PERFORMED TO RESOLVE THE ISSUE. THE PROCEDURE WAS EXTENDED FOR AN UNKNOWN DURATION.

  Patient problems: Tissue Breakdown

  MAUDE report 25247493 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OPERATIVE LAPAROSCOPIC LOWER ANTERIOR RESECTION, A LEAK OCCURRED AT STAPLE LINE. THE INCISION WAS EXTENDED FOR MORE THAN ONE INCH. THE LAPAROSCOPIC PROCEDURE WAS CONVERTED TO OPEN UNRELATED TO DEVICE PROBLEM. THE SURGEON FELT THAT HE NEEDED TO OPEN TO GET TO THE STAPLE LINE LEAK. INSTEAD COLOSTOMY CREATION WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14078777 ↗