Tri-Staple 2.0 SIG60AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521808973), received between Sep 13, 2022 and Sep 28, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Misfire” (3 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. 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 12 most recent of 12 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 50925862 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50925675 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50925408 ↗
• MalfunctionSep 22, 2026Material Separation; Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50859173 ↗
• MalfunctionSep 18, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830947 ↗
• MalfunctionAug 27, 2026Misfire

  It was reported that during the hepaticojejunostomy, there was an incomplete firing of the staple load. The surgeon sutured the part where the stapler did not complete its firing.

  Patient problems: Tissue Breakdown

  MAUDE report 50486860 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: Tissue Breakdown

  MAUDE report 50464506 ↗
• MalfunctionAug 10, 2026Misfire

  It was reported that during a laparoscopic sigmoid colon procedure at the sigmoid transection step, the device fired halfway. The surgeon resected and re-stapled to address the intraoperative issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50193604 ↗
• MalfunctionMar 30, 2026Retraction Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE PARTIALLY FIRED, BECAME LODGED ON THE SPECIMEN, AND BECAME STUCK, REQUIRING REMOVAL BY CUTTING IT OUT OF THE PATIENT¿S BODY. THESE COMPLICATIONS LED TO AN EXTENDED SURGICAL TIME. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING USING A NEW RELOAD, PLI40 MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT SEVERAL MILLIMETERS OF MATERIAL WERE FOUND TO BE SHEARED FROM THE DISTAL END OF THE FIRING ROD. PLI50: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND , THE INCOMPLETE RETRACTION COULD BE TRACED TO THE DAMAGE TO THE FIRING ROD OF RETURNED ADAPTER. PLI60: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND , THE INCOMPLETE RETRACTION COULD BE TRACED TO THE DAMAGE TO THE FIRING ROD OF RETURNED ADAPTER. PLI70: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND , THE INCOMPLETE RETRACTION COULD BE TRACED TO THE DAMAGE TO THE FIRING ROD OF RETURNED ADAPTER .

  Patient problems: Insufficient Information

  MAUDE report 24724057 ↗
• MalfunctionJun 16, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, STAPLING OF THE STOMACH, CLAMSHELL DID NOT WORK, THE SHELL WORKED TO ALLOW THE SURGEON TO OPEN OR CLOSE THE JAW OF THE CARTRIDGE AS WELL AS ARTICULATE, BUT WHEN THE SAFETY WAS REMOVED IT WOULD NOT FIRE THE 3RD RELOAD. A NEW SHELL WAS OPENED TO RESOLVE THE ISSUE AND USED TO THE SAME HANDLE AND ADAPTER BUT NEW RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146435 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE PATIENT HAD SUSPECTED POST-OPERATIVE COMPLICATIONS AND DELAYED STAPLE LINE BLEEDING AT THE GASTRIC REMNANT. THE BLEEDING WAS DISCOVERED THROUGH CT-SCAN. BLOOD LOSS WERE 3-4 UNITS. THE PATIENT STAYED IN THE HOSPITAL FOR ONE EXTRA POST-OPERATIVE DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16403218 ↗
• MalfunctionSep 13, 2022Unintended System Motion; Misfire; Unintended System Motion; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC SEGMENTAL RESECTION, WHILE THE LUNG PARENCHYMA WAS BEING RESECTED, THE FIRING STOPPED HALFWAY AND COULD NOT PROPERLY FIRE UNTIL THE END AND RETURNED AT THE HALF POSITION OF THE STAPLE. THE DEVICE WAS USED WITH ARTICULATION. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412122 ↗