Tri-Staple 2.0 SIG45AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521808966), received between Aug 27, 2026 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Misfire” (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 2 most recent of 2 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 50925523 ↗
• MalfunctionAug 27, 2026Misfire

  It was reported that during a laparoscopic ileostomy takedown, when the stapler was fired across the small bowel and stopped approximately halfway through firing, about 15 mm in, and would not re-engage or fire again. The reload was removed and replaced with another 45 mm tan reload using the same powered stapler handle and sterile shell. The replacement reload functioned properly, and the procedure continued. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50466457 ↗