Tri-Staple 2.0Recalls & reported problems across all models

We found 37 models of Tri-Staple 2.0 by Covidien LP in the FDA's device registry (GUDID). Together they are named in 4,892 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Sep 29, 2026 — classified as 15 deaths, 802 injuries, 4,075 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1,461 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tri-Staple 2.0 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 15, 2024Open, Classified

   Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

   Z-1891-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 25, 2023Open, Classified

   Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

   Z-1228-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported Tri-Staple 2.0 problems

Tri-Staple 2.0 models

37 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tri-Staple 2.0 SIG60AXT

  STAPLE, IMPLANTABLE
  1 recall3 deaths942 reports
• Tri-Staple 2.0 SIGTRSB60AMT

  STAPLE, IMPLANTABLE
  778 reports
• Tri-Staple 2.0 SIGTRSB60AXT

  STAPLE, IMPLANTABLE
  1 recall1 death615 reports
• Tri-Staple 2.0 SIG45AXT

  STAPLE, IMPLANTABLE
  342 reports
• Tri-Staple 2.0 SIGTRS60AMT

  STAPLE, IMPLANTABLE
  1 death309 reports
• Tri-Staple 2.0 SIGTRS60AXT

  STAPLE, IMPLANTABLE
  292 reports
• Tri-Staple 2.0 SIG30CTAVM

  STAPLE, IMPLANTABLE
  3 deaths236 reports
• Tri-Staple 2.0 SIG45CTAVM

  STAPLE, IMPLANTABLE
  2 deaths198 reports
• Tri-Staple 2.0 SIG30AVM

  STAPLE, IMPLANTABLE
  3 deaths137 reports
• Tri-Staple 2.0 SIGRADMT

  STAPLE, IMPLANTABLE
  118 reports
• Tri-Staple 2.0 SIGTRSB45AXT

  STAPLE, IMPLANTABLE
  107 reports
• Tri-Staple 2.0 SIG30CTAV

  STAPLE, IMPLANTABLE
  1 death91 reports
• Tri-Staple 2.0 SIGTRSB45AMT

  STAPLE, IMPLANTABLE
  88 reports
• Tri-Staple 2.0 SIGC60MT

  STAPLE, IMPLANTABLE
  81 reports
• Tri-Staple 2.0 SIG45CTAMT

  STAPLE, IMPLANTABLE
  80 reports
• Tri-Staple 2.0 SIGRADXT

  STAPLE, IMPLANTABLE
  70 reports
• Tri-Staple 2.0 SIG30AMT

  STAPLE, IMPLANTABLE
  59 reports
• Tri-Staple 2.0 SIG60CTAMT

  STAPLE, IMPLANTABLE
  58 reports
• Tri-Staple 2.0 SIGTRS45AMT

  STAPLE, IMPLANTABLE
  55 reports
• Tri-Staple 2.0 SIGTRS45AXT

  STAPLE, IMPLANTABLE
  38 reports
• Tri-Staple 2.0 SIG45CTAV

  STAPLE, IMPLANTABLE
  37 reports
• Tri-Staple 2.0 SIGC60VM

  STAPLE, IMPLANTABLE
  29 reports
• Tri-Staple 2.0 SIG60CTAVM

  STAPLE, IMPLANTABLE
  29 reports
• Tri-Staple 2.0 SIG30AV

  STAPLE, IMPLANTABLE
  27 reports
• Tri-Staple 2.0 SIGCIR28MT

  Staple, implantable
  1 death21 reports
• Tri-Staple 2.0 SIG60AMT

  Staple, implantable
  12 reports
• Tri-Staple 2.0 SIGCIR28XT

  Stapler, surgical
  10 reports
• Tri-Staple 2.0 SIG60AVM

  Staple, implantable
  8 reports
• Tri-Staple 2.0 SIG45AMT

  Staple, implantable
  5 reports
• Tri-Staple 2.0 SIGC60VT

  STAPLE, IMPLANTABLE
  4 reports
• Tri-Staple 2.0 SIGC45VM

  STAPLE, IMPLANTABLE
  4 reports
• Tri-Staple 2.0 SIGCIR31MT

  Staple, implantable
  4 reports
• Tri-Staple 2.0 SIGC45MT

  STAPLE, IMPLANTABLE
  2 reports
• Tri-Staple 2.0 SIGCIR31XT

  Stapler, surgical
  2 reports
• Tri-Staple 2.0 SIG45AVM

  Staple, implantable
  2 reports
• Tri-Staple 2.0 SIGC60V

  STAPLE, IMPLANTABLE
  1 report
• Tri-Staple 2.0 SIG45AV

  Staple, implantable
  1 report

Recent Tri-Staple 2.0 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Cut

  It was reported that during the video-assisted thoracoscopic surgery, two reloads stapled but did not cut at all. The procedure time was extended by 10 minutes. The device was replaced, and a new reload was purchased to resolve the issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50934872 ↗
• 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 50925523 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50925408 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50925364 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Tissue Breakdown

  MAUDE report 50919866 ↗
• MalfunctionSep 28, 2026Entrapment of Device; Retraction Problem

  It was reported that during a right upper lobe wedge resection, after an initial firing and loading a reload, the stapler displayed zero reloads. A reinforced reload was then used and fired; however, the knife blade failed to retract, and the reload became lockedon tissue and could not be removed. Attempts to open the reload branches with a screwdriver were unsuccessful. Another reload was used to re-staple beneath the stuck staple line, and additional right upper lobe tissue was resected. There was no patient injury. PLI50: Product was received without accompanying information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916666 ↗
• MalfunctionSep 28, 2026Misfire

  According to the reporter, during the laparoscopic assisted distal gastrectomy, when applied at the stomach, partial firing occurred midway. A new cartridge was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914909 ↗
• 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 ↗
• MalfunctionSep 23, 2026Failure to Fire; Expulsion

  According to the reporter, during a partial lung resection, at the time of parenchymal resection, the lung parenchyma was clamped with a black reload, and an attempt was made to fire, but the staple did not advance. It was noted that the staple came out around the proximal side of the cartridge's jaw. The cartridge and handle were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864852 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864537 ↗
• MalfunctionSep 23, 2026Break

  According to the reporter, during a laparoscopic pancreatic resection, a yellow tab fell into the patient¿s abdominal cavity, but it was removed without changing the technique, and all parts were confirmed to have been retrieved. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863587 ↗
• MalfunctionSep 23, 2026Difficult to Remove; Detachment of Device or Device Component

  It was reported that during a robotic-assisted left colectomy, the device was fired and the screen showed the anvil was tilting before removal. After removal, the device was examined and the reload had become detached from the adapter. The reload came off as the integrated trocar extended and prevented the anvil from tilting. After troubleshooting, the reload was able to be returned to the adapter and allowed the anvil to tilt normally. No patient harm or complications. After the case, the adapter and handle were tested with a fresh reload without any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863570 ↗
• MalfunctionSep 23, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863109 ↗

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