Tri-Staple 2.0 SIG30AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10884521543669), received between Oct 10, 2017 and Aug 12, 2026 — classified as 3 deaths, 39 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (43 reports).

14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220789 ↗
• MalfunctionMar 26, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY FOR APPENDICITIS, THE FIRING COULD NOT BE PERFORMED. THE HANDLE WAS LEFT AS IS, AND A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706380 ↗
• MalfunctionDec 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON POST OPERATIVE LAPAROSCOPIC GASTRIC BYPASS, A MANUAL STAPLER AND MULTIPLE RELOADS WERE USED AFTER THREE COMPETITIVE STAPLERS FAILED TO STAPLE OVER THE TISSUE. THE MANUAL STAPLER AND RELOADS WERE ABLE TO STAPLE THE TISSUE HOWEVER THE SURGEON SAID THAT THERE WAS OOZING/BLEEDING OF STAPLE LINE FOR THE FOUR RELOADS. THE SURGEON HAD TO PUT A DRAIN IN THE PATIENT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINS AS THE SURGEON NEEDED TIME TO CONTROL THE BLEEDING SURGICALLY. THE SURGEON HAD TO GIVE INTRA-OPERATIVE TRANEXAMIC ACID AND STOP POST-OPERATIVE PHARMACOLOGICAL VTE PROPHYLAXIS TO AVOID MORE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23892689 ↗
• MalfunctionDec 13, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANTATION PROCEDURE INVOLVING A RIGHT HEPATECTOMY, A STAPLER WAS USED TO STAPLE AND SECTION THE RIGHT HEPATIC VEIN WHEN A CRACKING NOISE OCCURRED, THE HANDLE/TRIGGER BROKE, AND THE RELOAD BECAME LOCKED ONTO THE LIVER AND COULD NOT BE REMOVED, RESULTING IN MORE THAN 30 MINUTES OF EXTENDED SURGICAL TIME. OBSERVED CLINICAL CONSEQUENCES INCLUDED AN ACUTE BLEEDING RISK THAT REQUIRED AN EMERGENCY AND RISKY CLAMPING TO PREVENT HEMORRHAGE, AND THE COMPLETION OF THE HEPATECTOMY WAS DESCRIBED AS DELICATE AND RUSHED. AS PRECAUTIONARY MEASURES, THE VEIN WAS CLAMPED, THE EQUIPMENT WAS LEFT IN PLACE, AND THE STAPLING LINE ON THE SURGICAL SPECIMEN WAS CUT FOR PRESERVATION.

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

  MAUDE report 23797156 ↗
• MalfunctionDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, ON FOUR DEVICES, A POSITIVE LEAK TEST WAS OBSERVED FOR EACH DEVICE, AND THE STAPLE LINE WAS FOUND TO BE LEAKING THE CONTENTS BEING HELD BY THE TISSUE. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23795279 ↗
• MalfunctionDec 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THERE WAS STAPLE FORMATION ISSUE. IT WAS NOTED THAT THERE WAS AN UNFORMED STAPLE LINE. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT TO RESOLVE THE DEVICE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23716334 ↗
• MalfunctionNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LOBECTOMY, EXCESSIVE BLEEDING OCCURRED FROM STAPLE LINES AFTER FIRING OVER THE PULMONARY VEIN AND PULMONARY ARTERY USING THE. STAPLE LINE BLEEDING WAS NOTED ON ALL FOUR FIRINGS. BLEEDING WAS RESOLVED WITH THE APPLICATION OF CLIPS AND PRESSURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23665705 ↗
• MalfunctionNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LOBECTOMY, EXCESSIVE BLEEDING OCCURRED FROM STAPLE LINES AFTER FIRING OVER THE PULMONARY VEIN AND PULMONARY ARTERY USING THE. STAPLE LINE BLEEDING WAS NOTED ON ALL FOUR FIRINGS. BLEEDING WAS RESOLVED WITH THE APPLICATION OF CLIPS AND PRESSURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23665647 ↗
• MalfunctionNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LOBECTOMY, EXCESSIVE BLEEDING OCCURRED FROM STAPLE LINES AFTER FIRING OVER THE PULMONARY VEIN AND PULMONARY ARTERY USING THE. STAPLE LINE BLEEDING WAS NOTED ON ALL FOUR FIRINGS. BLEEDING WAS RESOLVED WITH THE APPLICATION OF CLIPS AND PRESSURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23665537 ↗
• MalfunctionOct 16, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC APPENDECTOMY, THE RELOAD FIRED BUT FAILED TO STRAIGHTEN AFTER DEPLOYMENT, RESULTING IN THE TROCAR DISLODGING FROM THE PATIENT UPON REMOVAL. THE CASE WAS CONTINUED AS THE STAPLER WAS REMOVED IN THE ARTICULATED STUCK POSITION AND PULLED THE TROCAR OUT OF THE PEDIATRIC PATIENT TO REMOVE THE STAPLER AFTER COMPLETING FIRING.

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

  MAUDE report 23319912 ↗
• MalfunctionSep 4, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RESECTION OF THE RENAL ARTERY DURING DONOR NEPHRECTOMY, THE SURGEON ATTEMPTED TO APPROACH THE RENAL ARTERY WITH THE RELEVANT PRODUCT, CLAMPED THE ARTERY, AND PERFORMED STAPLING, BUT FIRING COULD NOT BE PERFORMED AT ALL. RESECTION WAS PERFORMED USING A NEW RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22972737 ↗
• MalfunctionSep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING SURGERY, THE PATIENT EXPERIENCED DIGESTIVE HEMORRHAGE 48 HOURS AFTER THE PROCEDURE INVOLVING THE SIX RELOADS. THE PATIENT RECOVERED AND NOTHING WAS DONE RESOLVED THE BLEEDING.

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

  MAUDE report 22931428 ↗
• MalfunctionSep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A GASTRIC BYPASS, A PATIENT PRESENTED WITH HEMATOCHEZIA FOLLOWING DISCHARGE. THE EVENT WAS ASSOCIATED WITH THE USE OF FIVE RELOADS, ALL USED WITH A POWERED STAPLER AND STANDARD ADAPTER. NO INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22931056 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A GASTRIC BYPASS, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING FROM THE FOUR RELOADS AFTER FIRING. FIVE DAYS AFTER THE PROCEDURE, BLOOD IN THE STOOL WAS OBSERVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR FIVE DAYS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. NO INTERVENTION WAS PERFORMED TO ADDRESS THE STAPLE LINE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22922564 ↗
• MalfunctionAug 20, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SURGEON CLAMPED ON THE TISSUE AND PRESSED THE FIRING MODE BUTTON HOWEVER THE STAPLER WOULD NOT FIRE. THE SALES REPRESENTATIVE ASKED THE SURGEON TO RETRACT THE TOGGLE BACK TO DISENGAGE. THE SURGEON DID NOT WANT TO USE THE RELOAD NOR THE SAME STAPLER, SO A NEW HANDLE AND A NEW RELOAD FROM THE SAME BATCH WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847190 ↗
• MalfunctionJun 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING THE HEPATECTOMY, THE DEVICE CANNOT BE STAPLED ONCE THE CLAMP IS IN PLACE AND LOCKED. ANOTHER HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324705 ↗
• MalfunctionMay 23, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A OPEN APPENDECTOMY RESECTION, AFTER CLAMPING THE TISSUE, THE HANDLE FOR THE FIRING COULD NOT BE SQUEEZED. THERE WERE NO PROBLEMS WITH THE OPENING AND CLOSING OF THE JAW; HOWEVER, THE JAW WAS CLOSED CONTRARY TO THE INTENTION FROM THE BEGINNING. THE HANDLE WAS REPLACED AT FIRST, BUT IT COULD NOT BE CLAMPED DUE TO THE SAME EVENT, SO THE CARTRIDGE WAS REPLACED AND THE FIRING COULD BE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081913 ↗
• InjuryMay 16, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACIC SURGERY, LEAKAGE OCCURRED FROM THE STAPLE LINE WHILE STAPLING THE PULMONARY ARTERY, FOLLOWED BY ARTERIAL TEARING ASSOCIATED WITH LOOSE STAPLES. AS A RESULT, THE PROCEDURE WAS CONVERTED TO AN EMERGENCY OPERATION, REQUIRING IMMEDIATE CLAMPING AND SUTURING OF THE ARTERY. THE PATIENT EXPERIENCED AN EXTENDED HOSPITALIZATION LASTING FOUR DAYS.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Tissue Breakdown

  MAUDE report 22036180 ↗
• InjuryApr 24, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A RIGHT LOBE LIVER RESECTION (HEPATECTOMY) AND CHOLECYSTECTOMY, AFTER FINISHING THE RESECTION, THE SPECIMEN WAS REMOVED, AND IT WAS SENT TO PATHOLOGY FOR ASSESSMENT. LAPS WERE PLACED AGAINST THE RESECTED LIVER, AND THE COMPRESSION WAS HELD FOR TEN MINUTES. AFTER TEN MINUTES, THE LAPS WERE REMOVED TO ASSESS THE LIVER, AND THIS WAS WHEN THE SURGEON REALIZED THE HOLE IN THE VENA CAVA AND THERE WAS A MAJOR BLOOD LOSS. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING AND CALLED A CODE BLUE. A VASCULAR SURGEON WAS CALLED TO REPAIR THE BLEEDING ON THE VENA CAVA. THERE WAS A 1.5 LITER OF BLOOD LOSS. A WOUND VAC WAS PLACED IN PATIENT, AND THE SURGICAL TEAM CLOSED THE PATIENT LATER. THE PATIENT WAS STABILIZED AND MOVED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS STABLE AND RETURNED HOME.

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

  MAUDE report 21901703 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THREE DAYS AFTER A ONE ANASTOMOSIS GASTRIC BYPASS (OAGB) SURGERY, THERE WAS WOUND DEHISCENCE OF THE POUCH, SPECIFICALLY IN THE CENTRAL AREA. THE DEVICE INVOLVED WAS THE TRI 2.0 30 VSCLR MED 12MM. TO RESOLVE THE ISSUE, REOPERATION WAS PERFORMED, THE DEFECT WAS OVERSUTURED, AND DRAINS WERE PLACED. THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION BY 4 EXTRA DAYS.

  Patient problems: Tissue Breakdown; Wound Dehiscence

  MAUDE report 21679382 ↗
• MalfunctionFeb 26, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE WAS SET ON THE THIRD LEVEL OF ARTICULATION ON THE APPENDIX, THE GREEN BUTTON WAS PRESSED AND WHEN THE HANDLE IS SQUEEZED SLIGHTLY, THE HANDLE COULD NOT BE SQUEEZED; AND THE HANDLE COULD NOT RETURN TO THAT POINT. THE GREEN BUTTON WAS TRIED TO BE PRESSED FROM THE LEFT AND RIGHT FOR ABOUT 5 MINUTES, OR PULLING THE BLACK RETURN KNOB, AND EVEN IF THE BLACK RETURN KNOB WAS PULLED, THE JAW DID NOT OPEN AND THE HANDLE REMAINED STIFF. THE ARTICULATION LEVER WAS THEN RETURNED TO ITS STRAIGHT STATE AND WHEN THE GREEN BUTTON WAS PRESSED AGAIN, THE HANDLE CAN BE OPENED AND FIRING COULD BE DONE. AFTER FINISHING THE FIRING TO THE END, THE JAW WAS RELEASED USING THE BLACK RETURN KNOB, AND THE FIRING OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472152 ↗
• MalfunctionJan 28, 2025Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW HANDLE WAS USED WITH THE SAME RELOAD. IT WAS NOTED THAT THE PROCEDURE TIME WAS EXTENDED FOR 10 MINUTES. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. THE JAWS WERE OPEN. STAPLE PUSHERS WERE VISIBLE AT THE 2.2CM CUT LINE.

  Patient problems: Insufficient Information

  MAUDE report 21254474 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A MINI GASTRIC BYPASS, THERE WERE ISSUES AFTER FIRING SPECIFICALLY WITH STAPLE FORMATION. THE STAPLES ON THE DISTAL TIP OF THE STAPLE LINE WERE NOT WELL-FORMED CAUSING A LEAK AND THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 21207305 ↗
• MalfunctionJan 21, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MINI GASTRIC BYPASS (GASTROJEJUNEM ANASTOMOSIS), DURING THE USE OF THE RELOAD, THERE WERE ISSUES AFTER FIRING, SPECIFICALLY WITH STAPLE FORMATION. THE STAPLES ON THE DISTAL TIP OF THE STAPLE LINE WERE NOT WELL-FORMED, CAUSING A LEAK, AND THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END.

  Patient problems: Insufficient Information

  MAUDE report 21196880 ↗
• MalfunctionJan 21, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MINI GASTRIC BYPASS (GASTROJEJUNEM ANASTOMOSIS), DURING THE USE OF THE RELOAD, THERE WERE ISSUES AFTER FIRING SPECIFICALLY WITH STAPLE FORMATION. THE STAPLES ON THE DISTAL TIP OF THE STAPLE LINE WERE NOT WELL-FORMED, CAUSING A LEAK, AND THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END.

  Patient problems: Insufficient Information

  MAUDE report 21196738 ↗

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-1228-2023 · Jan 25, 2023 · Open, Classified
  Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• 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-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