Tri-Staple 2.0 SIG60AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 942 adverse event reports that list this exact device (DI 10884521543591), received between Dec 13, 2016 and Sep 28, 2026 — classified as 3 deaths, 171 injuries, 768 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (298 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K160176); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. 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 problems

Recent adverse event reports

The 25 most recent of 942 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Tissue Breakdown

  MAUDE report 50919866 ↗
• InjurySep 18, 2026Failure to Form Staple

  According to the reporter, during the thoracoscopic partial lung resection, at the time of lung parenchyma resection, bleeding occurred from the mid-section. It appears that a failure of formation occurred. Additional resection was performed, and additional suturing was carried out using a stapler. The procedure was converted to a lobectomy because the bleeding could not be controlled.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 50818765 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, postoperatively, the patient experienced several complications (fistulas) that had been noted in recent weeks, based on data collected from (b)(6) 2025 to the present. In (b)(6) 2026, five complications were reported within a five-day period, and eight complications were reported within a 24-day period. It was also noted that the patient was readmitted to the hospital. The patient was subsequently confirmed to be doing well and in good condition.

  Patient problems: Fistula

  MAUDE report 50217390 ↗
• MalfunctionJul 31, 2026Misfire; Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 50105829 ↗
• MalfunctionJul 31, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 50101347 ↗
• MalfunctionJun 30, 2026Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LEFT VIDEO ASSISTED THORACOSCOPY, WEDGE RESECTION LEFT UPPER LOBE LUNG, THE DEVICE FIRED, HOWEVER ONCE THE STAPLES AND KNIFE BLADE REACHED THE DISTAL TIP OF THE DEVICE, IT WOULD NOT RETRACT. THEREFORE WOULD NOT ALLOW THE JAW OF THE DEVICE TO OPEN AND RELEASE THE TISSUE. A NEW STAPLER WAS OPENED TO TRY AND OPEN THE STUCK STAPLE LOAD BUT WAS UNSUCCESSFUL. A NEW KIND OF STAPLER RECOMMENDED BY THE REPRESENTATIVE WAS USED TWICE BUT WAS ALSO UNSUCCESSFUL. THE TISSUE AROUND THE RELOAD WAS RESECTED TO GET THE RELOAD OUT OF THE PATIENT'S CAVITY USING A NEW STAPLER. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 25669772 ↗
• MalfunctionJun 8, 2026Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, THE RELOAD WOULD NOT FIRE AND HAVE INDICATED ¿0¿ WITH A RED SCREEN.

  Patient problems: Insufficient Information

  MAUDE report 25423448 ↗
• MalfunctionMay 21, 2026Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) WEDGE RESECTION, A BLACK LOAD WAS FIRED ON LUNG TISSUE AND COULD NOT BE REMOVED FROM THE TISSUE, PREVENTING RETRACTION. THE SURGEON ATTEMPTED TO REMOVE THE CARTRIDGE MANUALLY BY GRASPING THE SLED BUT WAS UNSUCCESSFUL. TWO MORE STAPLERS WERE OPENED IN THE PROCESS OF TRYING TO REMOVE THE DEVICE. AFTER A TIME, THE DEVICE RELEASED THE TISSUE AFTER BEING FORCED BY THE SURGEON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239218 ↗
• MalfunctionMay 14, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WITH THE SAME CODE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172463 ↗
• MalfunctionMay 5, 2026Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A WEDGE RESECTION, WHEN FIRING THE DEVICE, THE SURGEON HEARD A LOUD CRACKING NOISE. THE SURGEON WENT TO REPURPOSE THE RELOAD ON THE TISSUE, BUT THE DEVICE COULD NOT BE FIRED. THE SURGEON RPEORTED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082235 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 20 DAYS POST-OPERATIVELY ON AN OPEN BOWEL RESECTION, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH INFECTION AND WAS SEPTIC DUE TO THE STAPLE LINE NOT HOLDING ON THE RECTAL STUMP. THREE RELOADS WERE USED AND HAD THE SAME ISSUE. AN OPEN REPAIR OF RECTAL STUMP DEHISCENCE AND OPEN REPAIR OF COLOTOMY WERE PERFORMED, AND SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. AN ANTIBIOTIC WAS ALSO PROVIDED FOR THE TREATMENT OF SEPSIS AND THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT (ICU) AFTER PROCEDURE.

  Patient problems: Laceration(s); Sepsis; Unspecified Infection

  MAUDE report 25028803 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 20 DAYS POST-OPERATIVELY ON AN OPEN BOWEL RESECTION, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH INFECTION AND WAS SEPTIC DUE TO THE STAPLE LINE NOT HOLDING ON THE RECTAL STUMP. THREE RELOADS WERE USED AND HAD THE SAME ISSUE. AN OPEN REPAIR OF RECTAL STUMP DEHISCENCE AND OPEN REPAIR OF COLOTOMY WERE PERFORMED, AND SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. AN ANTIBIOTIC WAS ALSO PROVIDED FOR THE TREATMENT OF SEPSIS AND THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT (ICU) AFTER PROCEDURE.

  Patient problems: Laceration(s); Sepsis; Unspecified Infection

  MAUDE report 25021704 ↗
• MalfunctionApr 17, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING A VATS (VIDEO-ASSISTED THORACIC SURGERY) LOBECTOMY, THE RELOAD AUTOMATICALLY CLOSED DURING LEFT ARTICULATION AND CLAMPED TISSUE. THE RELOAD DID NOT REOPEN AFTER AUTO-CLOSING, AND FORCED ACTIVATION OF RESECTION WAS PERFORMED TO ALLOW THE RELOAD TO OPEN. IT WAS ALSO REPORTED THAT ANOTHER RELOAD FROM THE SAME BATCH EXHIBITED THE SAME ISSUE DURING LEFT ARTICULATION. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. A NEW RELOAD WAS SUED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912771 ↗
• MalfunctionApr 17, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING A VATS (VIDEO-ASSISTED THORACIC SURGERY) LOBECTOMY, THE RELOAD AUTOMATICALLY CLOSED DURING LEFT ARTICULATION AND CLAMPED TISSUE. THE RELOAD DID NOT REOPEN AFTER AUTO-CLOSING, AND FORCED ACTIVATION OF RESECTION WAS PERFORMED TO ALLOW THE RELOAD TO OPEN. IT WAS ALSO REPORTED THAT ANOTHER RELOAD FROM THE SAME BATCH EXHIBITED THE SAME ISSUE DURING LEFT ARTICULATION. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. A NEW RELOAD WAS SUED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912755 ↗
• MalfunctionApr 14, 2026Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN THORACOTOMY LUNG RESECTION, DURING THE TRANSECTION OF THE LUNG, FOUR HANDLES BROKE. THE HANDLES ALL CRACKED DURING FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE PARTIALLY FIRED AND HAD A DEFORMED CLAMPING MECHANISM DUE TO THICK TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24870653 ↗
• MalfunctionApr 6, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THERE WAS PARTIAL FIRING. THE STAPLE ADVANCED ABOUT 3CM AND THE FIRING STOPPED. IT WAS ALSO NOTED THAT THE JAW WAS OPENED AND THE KNIFE DID NOT ADVANCE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24794552 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, THERE WAS AN EXCESS BLEEDING ON THE STAPLE LINE FROM THE TWO RELOADS. EXCESSIVE CLIPPING WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24753042 ↗
• MalfunctionMar 30, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE POWERED STAPLER WAS NOT FULLY FIRED. THE STAPLER STOPPED AFTER 2 CM AND WOULD NOT CONTINUE FIRING. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712052 ↗
• InjuryMar 25, 2026Misfire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PLEUROSCOPY FOR PNEUMOTHORAX CURE PROCEDURE, THE HANDLE WAS FORCE; THE STAPLING PROCESS DID NOT COMPLETE ALL THE WAY, AND THE HANDLE SUBSEQUENTLY GOT LOCKED AND BROKE. THE TWO 60MM RELOADS FAILED UNDER PRESSURE. UNDER THESE CIRCUMSTANCES, THE PROCEDURE WAS CONVERTED, A SHORT POSTEROLATERAL THORACOTOMY IS PERFORMED THROUGH THE 4TH INTERCOSTAL SPACE. THE ATYPICAL EXCISION OF THE PULMONARY LESION IS COMPLETED USING COLD SCISSORS. HEMOSTASIS IS ACHIEVED USING INTERRUPTED CROSS-STITCHES WITH 4-0 SUTURE FROM ANOTHER MANUFACTURER. AN AIR-LEAK TEST IS PERFORMED, REVEALING MODERATE BUBBLING IN THE AREAS WHERE THE PLEURA HAD BEEN STRIPPED. SEVERAL LONG RUNNING 3-0 SUTURES ARE PLACED TO COVER ALL AREAS POTENTIALLY RESPONSIBLE FOR THE AIR LEAK. NO NOTABLE COMPLICATIONS REGARDING THE OPERATIVE SITE OCCURRED DURING THE HOSPITAL STAY. THE CHEST DRAIN WAS REMOVED ON DAY 4. FOLLOW-UP CHEST X-RAYS DEMONSTRATED RESOLUTION OF THE PNEUMOTHORAX, WITH NO ADDITIONAL PATHOLOGICAL FINDINGS. PAIN WAS CONTROLLED WITH ANALGESICS. THE PATIENT REMAINED AFEBRILE THROUGHOUT HOSPITALIZATION.

  Patient problems: Laceration(s); Pain

  MAUDE report 24683727 ↗
• InjuryMar 24, 2026Misfire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PLEUROSCOPY FOR PNEUMOTHORAX CURE PROCEDURE, THE HANDLE WAS FORCE; THE STAPLING PROCESS DID NOT COMPLETE ALL THE WAY, AND THE HANDLE SUBSEQUENTLY GOT LOCKED AND BROKE. THE TWO 60MM RELOADS FAILED UNDER PRESSURE. UNDER THESE CIRCUMSTANCES, THE PROCEDURE WAS CONVERTED, A SHORT POSTEROLATERAL THORACOTOMY IS PERFORMED THROUGH THE 4TH INTERCOSTAL SPACE. THE ATYPICAL EXCISION OF THE PULMONARY LESION IS COMPLETED USING COLD SCISSORS. HEMOSTASIS IS ACHIEVED USING INTERRUPTED CROSS-STITCHES WITH 4-0 SUTURE FROM ANOTHER MANUFACTURER. AN AIR-LEAK TEST IS PERFORMED, REVEALING MODERATE BUBBLING IN THE AREAS WHERE THE PLEURA HAD BEEN STRIPPED. SEVERAL LONG RUNNING 3-0 SUTURES ARE PLACED TO COVER ALL AREAS POTENTIALLY RESPONSIBLE FOR THE AIR LEAK. NO NOTABLE COMPLICATIONS REGARDING THE OPERATIVE SITE OCCURRED DURING THE HOSPITAL STAY. THE CHEST DRAIN WAS REMOVED ON DAY 4. FOLLOW-UP CHEST X-RAYS DEMONSTRATED RESOLUTION OF THE PNEUMOTHORAX, WITH NO ADDITIONAL PATHOLOGICAL FINDINGS. PAIN WAS CONTROLLED WITH ANALGESICS. THE PATIENT REMAINED AFEBRILE THROUGHOUT HOSPITALIZATION.

  Patient problems: Laceration(s); Pain

  MAUDE report 24679299 ↗
• MalfunctionMar 23, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE ASSEMBLING THE DEVICE, THE RELOAD DID NOT FOLLOW THE ASSEMBLY ROTATION CORRECTLY AND BECAME STUCK HALFWAY. ATTEMPTS TO REMOVE THE RELOAD BY COUNTERCLOCKWISE ROTATION WERE UNSUCCESSFUL. WHEN FORCE WAS APPLIED, THE REAR PART OF THE RELOAD CAME APART. THE MANUAL HANDLE AND THE RELOAD COULD NO LONGER BE USED AFTER THE INCIDENT. THE CONNECTION PART WAS NOTED TO BE VERY LOOSE BEFORE ASSEMBLY, AS IF DETACHED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665289 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC GASTRIC SLEEVE, STAPLE LINE BLEEDING WAS OBSERVED 10¿15 MINUTES AFTER FIRING FOUR RELOADS. ALL STAPLE LINES REQUIRED CLIPPING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24631937 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC GASTRIC SLEEVE, STAPLE LINE BLEEDING WAS OBSERVED 10¿15 MINUTES AFTER FIRING FOUR RELOADS. ALL STAPLE LINES REQUIRED CLIPPING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24630013 ↗
• MalfunctionMar 13, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PULMONARY LOBECTOMY, THE TWO BLACK 60MM RELOADS FAILED IN THE PARENCHYMA. AFTER STAPLING, THE STAPLE LINE WAS OBSERVED TO BE POORLY FORMED (INCOMPLETE CENTRALLY); THE STAPLES WERE NOT PERFECTLY ALIGNED AS THE STAPLE FORMATION WAS NOT FORMED CORRECTLY IN THE B SHAPE. THE PURPLE 45MM RELOAD WAS USED IN THE BRONCHUS, IT WAS STAPLED BUT AFTER A FEW MINUTES THE STAPLE LINE OPENED UP. TROUBLESHOOTING INVOLVED REPLACING THE RELOADS, WHICH WERE FROM THE SAME BATCH AS THE ONES REPLACED, AND USING THE SAME ADAPTER AND HANDLE. AFTER REPLACEMENT, THE STAPLE LINE WAS PROPERLY STAPLED. THE PROCEDURE WAS EXTENDED BY 45 MINUTES AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 24596889 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURES, POSTOPERATIVE BLEEDING OCCURRED ON THE STAPLE LINE. THE PATIENT REQUIRED A BLOOD TRANSFUSION DURING THE SAME HOSPITALIZATION AND STAYED AN EXTRA DAY IN THE HOSPITAL DUE TO THE EVENT. THE PATIENT RECEIVED AN ANTICOAGULANT 12 HOURS AFTER SURGERY AS PART OF THE PROTOCOL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24567681 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176. One submission often covers many models, so check the product and lot details in each record.

• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1237-2018 · Dec 13, 2017 · Terminated
  Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta