Tri-Staple 2.0 SIG30CTAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10884521543737), received between Dec 5, 2017 and Mar 30, 2026 — classified as 1 death, 12 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (42 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• 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, R EQUIRING 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 24724832 ↗
• 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, R ENQUIRING 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, 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 24724475 ↗
• MalfunctionJan 16, 2026Unintended Movement

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION, THE ARTICULATION PART OF THE CARTRIDGE WAS FOUND TO BE UNSTEADY AND WOBBLING MORE THAN USUAL PRIOR TO USE, SHOWING A SIGNIFICANT DIFFERENCE COMPARED TO A NEW CARTRIDGE. HOWEVER, FIRING WAS NOT PERFORMED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095263 ↗
• MalfunctionDec 30, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, IN A THORACOSCOPIC LEFT UPPER LOBECTOMY, WHILE IN THE BLOOD VESSEL, FIRING COULD NOT BE DONE AT ALL. STAPLES HAVE COME OUT AROUND THE PROXIMAL SIDE OF THE CARTRIDGE'S JAW. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929211 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), A PULMONARY ARTERY BRANCH WAS DIVIDED. APPROXIMATELY 60 MINUTES LATER, AS THE PATIENT WAS WAKING UP AND COUGHED, THE STAPLE LINE OPENED UP, RESULTING IN DEHISCENCE AND STAPLE LINE BLEEDING. THE PATIENT EXPERIENCED CARDIAC ARREST AND REQUIRED CARDIAC MASSAGE. THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN SURGERY. THE PATIENT RECOVERED WELL.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Organ Dehiscence

  MAUDE report 23891452 ↗
• MalfunctionDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THORACIC PROCEDURE, STAPLE LINE BLEEDING OCCURRED AFTER FIRING THE RELOAD WITH A MANUAL HANDLE. CLIPS WERE REQUIRED AND APPLIED TO CONTROL THE BLEEDING ON THE STAPLE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23730423 ↗
• MalfunctionNov 12, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A VASCULAR RESECTION PROCEDURE, THE FIRING COULD NOT BE DONE AT ALL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530742 ↗
• MalfunctionOct 28, 2025Component or Accessory Incompatibility; Detachment of Device or Device Component; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN AZYGOS VEIN RESECTION DURING ESOPHAGEAL RESECTION, DURING SETUP, THE RELOAD COULD NOT BE CONNECTED AND THE SHAFT COVER DETACHED. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410484 ↗
• MalfunctionSep 19, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER LOBECTOMY, ON BLOOD VESSEL RESECTION, THE GREEN BUTTON WAS PRESSED AND AN ATTEMPT WAS MADE TO FIRE/PERFORM FIRING, BUT THE KNIFE DID NOT ADVANCE AND THE FIRING COULD NOT BE PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096464 ↗
• MalfunctionSep 19, 2025Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER DURING A PROCEDURE, AFTER CONNECTING THE CARTRIDGE TO A POWERED HANDLE, THE SYSTEM INITIALLY DISPLAYED A USABLE OR CAN BE USED INDICATION. BUT WHEN AN ATTEMPT WAS MADE TO PERFORM SEALING, THE DEVICE WAS RECOGNIZED AS USED AND BECAME NON-FUNCTIONAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093866 ↗
• MalfunctionSep 4, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE SETTING UP, THE RELOAD WAS LOADED INTO THE HANDLE, IN TRYING TO CHECK THE OPENING AND CLOSING OF THE DEVICE, IT DID NOT WORK. THE USER TRIED TO DISCONNECT THE DEVICE, BUT IT STILL DID NOT WORK. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22966902 ↗
• MalfunctionAug 28, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY FOR MALIGNANT ESOPHAGEAL TUMOR, THE HANDLE COULD NOT BE SQUEEZED AND THE FIRING COULD NOT BE DONE AT ALL. IT WAS ALSO NOTED THAT THE STAPLE CAME OUT AROUND THE PROXIMAL SIDE OF THE CARTRIDGE¿S JAWS. THE HANDLE AND THE CARTRIDGE WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917085 ↗
• MalfunctionJul 23, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPICALLY ASSISTED PULMONARY RESECTION, THE FIRING COULD NOT BE COMPLETED AT ALL. THE PROCEDURE WAS CONTINUED WITHOUT DELAY BY REPLACING THE HANDLE AND CARTRIDGE WITH NEW UNITS OF THE SAME MODELS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579278 ↗
• MalfunctionMay 14, 2025Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ESOPHAGECTOMY, ON THE AZYGOS VEIN, THE FIRING WAS COMPLETED TO THE END, BUT AFTERWARDS, THE RELEASE BUTTON HAD TO BE PRESSED SEVERAL TIMES WHEN RETRACTING THE KNIFE. THE POWERED HANDLE AND SHELL WERE REPLACED TO RESOLVE THE ISSUE, AND THE SAME ADAPTER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018967 ↗
• MalfunctionMay 9, 2025Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A RIGHT LOWER LOBECTOMY, DURING PULMONARY ARTERY RESECTION, WHEN CLAMPED, THERE WAS NO ISSUE AT ALL. WHEN FIRING WAS ATTEMPTED, THE MOMENT THE DOWN BUTTON WAS PRESSED, THE FIRING ADVANCED ONLY FOR A MOMENT AND THEN IT STOPPED. THE SCREEN SHOWED EXCESSIVE FORCE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995380 ↗
• MalfunctionApr 17, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A PULMONARY LOBECTOMY, DURING VASCULAR PROCESSING, WHEN THE JAWS WERE CLOSED AND THE SURGEON PRESSED THE GREEN BUTTON, THE FIRING DID NOT ADVANCE. IT WAS FOUND THAT THE RELOAD WAS PRE-FIRED. A NEW CARTRIDGE WAS USED WITH THE SAME POWERED STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855011 ↗
• MalfunctionMar 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THE SHIPPING WEDGE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728433 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THE SHIPPING WEDGE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721126 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THE SHIPPING WEDGE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720804 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING THERE WAS LEAK FROM THE STAPLE LINE, IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose

  MAUDE report 21091042 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING, THERE WAS A LEAK FROM THE STAPLE LINE; IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED, AND DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 21090926 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING THERE WAS LEAK FROM THE STAPLE LINE, IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 21090560 ↗
• MalfunctionDec 13, 2024Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) UPPER RIGHT LOBECTOMY PROCEDURE, BEFORE USING THE DEVICE IN THE BLOOD VESSEL, THE SURGEON HAD DIFFICULTIES LOADING THE RELOAD TO THE HANDLE. AFTER THAT, THE GREEN BUTTON WAS PRESSED AND FIRING WAS ATTEMPTED, BUT IT DID NOT FIRE AT ALL. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931529 ↗
• MalfunctionOct 16, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) ESOPHAGECTOMY, AFTER THE FIRING WAS COMPLETED AND AFTER THE JAWS WERE OPENED TO RELEASE TO RELEASE THE TISSUE, THE ARTICULATION DID NOT RETURN TO ITS ORIGINAL POSITION, AND IT WAS DIFFICULT TO RETURN THE ARTICULATION TO ITS ORIGINAL POSITION, THAT CAUSED DAMAGE TO THE LOCK RING. IT WAS ALSO REPORTED THAT THE RELOAD WAS DIFFICULT TO UNLOAD. THE ARTICULATION WAS FORCIBLY CORRECTED AND THE TROCAR WAS REMOVED ALONG WITH THE STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461866 ↗
• MalfunctionAug 28, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) RIGHT S2 AREA RESECTION, IN THE PULMONARY ARTERY, THE DEVICE FIRING STOPPED BETWEEN THE ONE CENTIMETER (CM) AND 2CM FROM THE PROXIMAL SIDE. THE KNIFE WAS RETRACTED, AND 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 20092139 ↗

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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• 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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• 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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• 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