Tri-Staple 2.0 SIG45CTAVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 10884521543720), received between Sep 27, 2017 and Aug 7, 2026 — classified as 2 deaths, 52 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (57 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 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Misfire

  According to reporter, during the lung parenchymal resection, while at the third firing, the firing stopped about one-third from the tip. The stapler had almost completely come out. Partway through, there was a difference in how the staple pushers came out, and it appeared that there were areas where the staples were not properly pushed out. A new reload was taken out and the resection was continued. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184439 ↗
• InjuryJun 12, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, A CUT OCCURRED BUT STAPLES DID NOT DEPLOY. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AND THE PATIENT HAD TO UNDERGO MULTIPLE OTHER PROCEDURES DUE TO THIS ISSUE. EXTENDED HOSPITALIZATION WAS ALSO REPORTED.

  Patient problems: Tissue Breakdown

  MAUDE report 25481122 ↗
• MalfunctionApr 27, 2026Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT HEPATECTOMY, SPECIFICALLY AT THE TIME OF GLISSON SHEATH RESECTION. THE DEVICE EXPERIENCED PARTIAL FIRING AND STOPPED APPROXIMATELY 1 CM INTO ADVANCEMENT, THE PHYSICIAN ATTEMPTED TO ADVANCE IT AGAIN BUT WAS UNS UCCESSFUL, LEADING TO WITHDRAWAL. UPON A SUBSEQUENT FIRING ATTEMPT, THE DEVICE AGAIN STOPPED MIDWAY AND DISPLAYED AN EXCESSIVE FORCE WARNING, HOWEVER, PER THE PHYSICIAN¿S DECISION, FIRING WAS CONTINUED AND COMPLETED USING A SECOND DEVICE. THE ISSUE WAS RESOLVED BY REPLACING THE PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000585 ↗
• MalfunctionApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, IN PULMONARY VEIN, THE PATIENT CONTINUED TO BLEED AFTER STAPLES WERE FIRED. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

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

  MAUDE report 24982588 ↗
• MalfunctionFeb 5, 2026Misfire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON FIRED TWO MEDIUM/THICK LOADS TO COMPLETE ONE FISSURE AND THEN A VASCULAR LOAD TO DIVIDE A VENOUS BRANCH. ALL OF THAT WAS UNEVENTFUL. THE USER THEN WENT TO DIVIDE THE PULMONARY ARTERY TRUNCAL BRANCH AND A VASCULAR STAPLER LOAD DID NOT FIRE. THE NURSING STAFF CONFIRMED IT WAS A NEW STAPLE LOAD. NO INTERVENTION WAS DONE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: Insufficient Information

  MAUDE report 24273761 ↗
• MalfunctionFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE DIVIDING THE RIGHT UPPER LOBE BRONCHUS, THE STAPLER FAILED, AND THE BRONCHUS WAS NOT SEALED. THE SURGEON SUCCESSFULLY REPAIRED THE BRONCHUS THORACOSCOPICALLY WITHOUT ANY ENDOBRONCHIAL LEAK NOTED IN THE THEATER OR POSTOPERATIVELY BY SUTURING AS A STAPLE LINE REPLACEMENT. SURGICAL TIME WAS EXTENDED BY 20 MINUTES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY COMPLICATIONS.

  Patient problems: Tissue Breakdown

  MAUDE report 24235608 ↗
• MalfunctionJan 29, 2026Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PARENCHYMOTOMY ON A HEPATECTOMY, THE STAPLER BECAME STUCK IN THE CLOSED POSITION WITH NO POSSIBILITY OF REOPENING IT. DISSECTION WAS PERFORMED TO REPOSITION THE VASCULAR CLAMPS, AS WELL AS CUTTING THE VEIN ON THE COMMON TRUNK WITH SCISSORS, IN ORDER TO EXTRACT THE STAPLER. THIS RESULTED IN AN APPROXIMATE 90-MINUTE EXTENSION OF THE OPERATIVE TIME, BLEEDING, AND THE SACRIFICE OF THE MIDDLE HEPATIC VEIN.

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

  MAUDE report 24210447 ↗
• MalfunctionDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, THE STAPLE LINE BLED. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

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

  MAUDE report 23907575 ↗
• MalfunctionDec 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON FIRED TWO MEDIUM/THICK LOADS TO COMPLETE ONE FISSURE AND THEN A VASCULAR LOAD TO DIVIDE A VENOUS BRANCH. ALL OF THAT WAS UNEVENTFUL. THE USER THEN WENT TO DIVIDE THE PULMONARY ARTERY TRUNCAL BRANCH AND A VASCULAR STAPLER LOAD DID NOT FIRE. THE NURSING STAFF CONFIRMED IT WAS A NEW STAPLE LOAD. NO INTERVENTION WAS DONE TO RESOLVE THEISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839126 ↗
• MalfunctionDec 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, THE STAPLER WAS OPENED AND A PURPLE RELOAD WAS LOADED, CYCLED, AND CLOSED. WHEN THE SURGEON ATTEMPTED TO INSERT IT INTO THE PORT, THE JAWS WOULD NOT OPEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND REMAINED UNABLE TO BE OPENED. AFTER THE CASE, THE SCRUB NURSE MANAGED TO OPEN THE STAPLER BUT NOTED A ¿GRINDY¿ SENSATION WHEN TAKING THE RELOAD OFF. THE DEVICE WAS REPLACED WITH A NEW STAPLER AND RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823743 ↗
• MalfunctionDec 9, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) LUNG WEDGE RESECTION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, BUT THE HANDLE BECAME INCREASINGLY STICKY, THEN JAMMED AND COULD NOT FIRE. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760884 ↗
• MalfunctionAug 25, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN OPEN GASTRIC ANTRECTOMY PROCEDURE, WHEN SETTING UP, THERE WAS DIFFICULTY ATTACHING THE ADAPTER TO THE SHELL. SUBSEQUENTLY, THE RELOAD WAS NOT RETURNING TO THE NEUTRAL POSITION AFTER BEING FIRED IN AN ARTICULATED POSITION (STUTTERING AND NOT RETURNING TO STRAIGHT), AND THERE WAS MORE FORCE THAN NORMAL REQUIRED TO FULLY SEAT THE ADAPTER. IT WAS ALSO NOTED THAT THERELOAD WAS DIFFICULT TO UNLOAD. ANOTHER POWER HANDLE, ADAPTER AND SHELL WERE USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890069 ↗
• MalfunctionJul 21, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A SINGLE-PORT VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) LEFT UPPER LOBECTOMY, THE HANDLE WAS FULLY SQUEEZED BUT THE CARTRIDGE COULD NOT BE COMPLETELY CLOSED. THE ISSUE WAS RESOLVED BY REPLACING THE CARTRIDGE, AND THE HANDLE WAS CONFIRMED TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554655 ↗
• MalfunctionJul 18, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING STAPLING, THE STAPLES DID NOT DISPENSE. ANOTHER HANDLE AND RELOAD WERE USED BUT HAD THE SAME ISSUE. TO COMPLETE THE CASE, A THIRD DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546413 ↗
• MalfunctionJun 9, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING STAPLING, THE STAPLES DID NOT DISPENSE. ANOTHER DEVICE WAS USED, BUT IT MALFUNCTIONED. TO COMPLETE THE CASE, A THIRD DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166498 ↗
• MalfunctionJun 7, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY), THE FIRING COULD NOT BE ADVANCED AT ALL. A NEW HANDLE, ADAPTER, RELOAD AND SHELL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163930 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE RELOAD, THE SILVER SHAFT COVERING THE RELOAD CONNECTION POINT SLID AWAY, RENDERING THE INSTRUMENT UNUSABLE. THE RELOAD COMPONENT OF THE INSTRUMENT BROKE, SPECIFICALLY THE SHAFT. ANOTHER RELOAD OF THE SAME TYPE AND LOT NUMBER WAS OPENED AND USED WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119991 ↗
• MalfunctionMay 29, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, THE STAPLER HAD A STAPLING MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 22105030 ↗
• MalfunctionApr 29, 2025Misfire; Device Displays Incorrect Message; Mechanics Altered; Misfire; Device Displays Incorrect Message; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE ROBOT ASSISTED LOBECTOMY, THE RELOAD ERROR WITH YELLOW RELOAD STATUS INDICATOR (SWIM LANE) AND EXCLAMATION MARK WAS DISPLAYED, AND THE DEVICE WAS UNABLE TO BE USED. THE PRODUCT WAS REPLACED WITH A NEW RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21929426 ↗
• MalfunctionMar 24, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED LEFT LOWER LOBECTOMY, IN THE PULMONARY VEIN, AFTER CLOSING THE JAWS, THE SURGEON PRESSED THE GREEN BUTTON AND PUSHED THE CENTER CONTROL DOWNWARD. HOWEVER, THE DEVICE DID NOT FIRE AT ALL. HENCE, THE BLADE DID NOT ADVANCE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED WITH THE SAME POWERED DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681055 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY, AFTER FIRING OVER A VEIN, THE MIDDLE OF THE STAPLE LINE BLED. THE SCRUB TECHNICIAN REPORTED THAT THERE WAS AN ERROR ON THE SCREEN BEFORE FIRING THEN WENT AWAY. THE ERROR WAS UNKNOWN. THE PROCEDURE WAS CONVERTED TO OPEN TO STOP THE BLEEDING. THE SURGEON PUT PRESSURE ON VEIN TO STOP BLEEDING. THE SURGEON TRIED TO RE-STAPLE, BUT IT DID NOT WORK AND THE BLEEDING CONTINUED. A NEW ADAPTER WAS USED AND USED FOR THE REMAINDER OF THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unspecified Tissue Injury

  MAUDE report 21408087 ↗
• MalfunctionJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THERE WAS BLEEDING FROM THE STAPLE LINE AFTER FIRING THE RENAL HILUM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21283496 ↗
• MalfunctionJan 9, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THERE WERE FIRING ISSUES WITH THE HANDLE AND RELOAD DURING A VATS LOBECTOMY PROCEDURE. THE INSTRUMENTS DID NOT FIRE, AND ALTHOUGH THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON, USER WERE UNABLE TO SQUEEZE THE HANDLE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW HANDLE AND RELOAD. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117509 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER HAD MISFIRED WHICH LED TO EXCESSIVE BLEEDING ON THE STAPLE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21061542 ↗
• MalfunctionOct 2, 2024Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A RIGHT UPPER LOBECTOMY, ON THE RIGHT SUPERIOR PULMONARY VEIN, AFTER FIRING, IT WAS DIFFICULT TO RETRACT THE RETURN KNOB. AN ADDITIONAL RESECTION AND SUTURE WERE PERFORMED WITH A STAPLER TO RESOLVE THE ISSUE. THERE WAS AN EXTENSION OF SURGERY TIME OF 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 20351841 ↗

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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• 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