Tri-Staple 2.0 SIGTRSB45AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10884521717602), received between Apr 22, 2019 and Mar 24, 2026 — classified as 9 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Misfire” (42 reports).

2 other recalls cover devices cleared under the same FDA submission (K173270); 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING THE TOTAL GASTRECTOMY, THE FIRING COULD NOT BE PERFORMED WITH THE POWERED STAPLER. THE APPROPRIATE RELOAD WAS THEN ATTACHED TO THE STANDARD MANUAL STAPLER, AND AN ATTEMPT WAS MADE TO PERFORM FIRING, BUT THE FIRING AND RESECTION COULD NOT BE PERFORMED AS WELL. AFTER THAT, THE RELOAD WAS ALSO REPLACED, AND THE FIRING BECAME POSSIBLE. THE ISSUE WAS RESOLVED USING THE MANUAL STANDARD STAPLER WITH THE NEW RELOAD. ADDITIONALLY, THERE WAS EXPOSURE OF THE STAPLES AT THE PROXIMAL SITE OF THE JAWS AFTER THE CHECKING OF THE RELOAD. IT WAS NOTED THAT THE HANDLE AND ADAPTER FIRED WITH NO PROBLEM AFTER THE CARTRIDGE WAS REPLACED WITH ANOTHER ONE(DEMONSTRATION DEVICE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677540 ↗
• InjuryMar 23, 2026Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A GIANT PULMONARY CYST RESECTION, WHEN THE REINFORCE WAS INSERTED THROUGH THE SIXTH INTERCOSTAL SPACE TO RESECT A PULMONARY CYST, A CRACKING SOUND WAS HEARD, DUE TO EXCESSIVE FORCE APPLIED AT THE CONNECTION PART BETWEEN THE ADAPTER AND THE CARTRIDGE. UPON INSPECTION, THE CONNECTION WAS DAMAGED AND CAME OFF. A NEW CARTRIDGE WAS CONNECTED AND CHANGED TO AN APPROACH THROUGH THE FOURTH INTERCOSTAL SPACE, AND THE SURGERY WAS COMPLETED. AN X-RAY WAS USED TO CHECK FOR ANY REMAINING PARTS OF THE BODY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24669818 ↗
• MalfunctionMar 19, 2026Break; Firing Problem

  IT WAS REPORTED THAT DURING USE, THE RELOAD WAS DIFFICULT TO FIRE WHEN USED WITH A POWERED HANDLE AND STANDARD ADAPTER. THE DEVICE WAS REPLACED WITH A NEW RELOAD 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 THAT THE JAWS WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638038 ↗
• MalfunctionMar 5, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, ONLY 70% OF THE STAPLES FIRED. THE RELOAD WAS REPLACED AND EXCHANGED FOR A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24522870 ↗
• MalfunctionFeb 12, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, DURING A CLOSURE OF THE ENTRY SITE FOR THE GASTROJEJUNOSTOMY, WHEN THE FIRST 60 MM RELOAD WAS FIRED, THE FIRING STOPPED PARTWAY. AFTERWARDS, A 45 MM RELOAD WAS USED FOR FOLLOW-UP, BUT THE FIRING STOPPED PARTWAY AS WELL. A SECOND 45 MM RELOAD WAS USED AGAIN, BUT THE SAME ISSUE OCCURRED. IN THE END, MANUAL SUTURING WAS PERFORMED, INCLUDING THE PART WITH THE STOPPED STAPLE.

  Patient problems: Tissue Breakdown

  MAUDE report 24322080 ↗
• MalfunctionFeb 12, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, DURING A CLOSURE OF THE ENTRY SITE FOR THE GASTROJEJUNOSTOMY, WHEN THE FIRST 60 MM RELOAD WAS FIRED, THE FIRING STOPPED PARTWAY. AFTERWARDS, A 45 MM RELOAD WAS USED FOR FOLLOW-UP, BUT THE FIRING STOPPED PARTWAY AS WELL. A SECOND 45 MM RELOAD WAS USED AGAIN, BUT THE SAME ISSUE OCCURRED. IN THE END, MANUAL SUTURING WAS PERFORMED, INCLUDING THE PART WITH THE STOPPED STAPLE.

  Patient problems: Tissue Breakdown

  MAUDE report 24322078 ↗
• MalfunctionOct 21, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PARTIAL PULMONARY RESECTION, THE RELOAD WAS CONNECTED TO A POWERED HANDLE WITH A STANDARD ADAPTER, BUT FIRING COULD NOT BE PERFORMED AT ALL, DESPITE THE JAW BEING FULLY CLOSED AND THE USER SUCCESSFULLY PRESSING THE GREEN BUTTON. A NEW RELOAD WAS USED, ALLOWING THE PROCEDURE TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347532 ↗
• MalfunctionAug 19, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LUNG SURGERY, THE KNIFE SLIGHTLY ADVANCED AND THEN STOPPED MOVING AT ALL. THE FIRING WAS UNABLE TO BE PERFORMED HALFWAY. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842357 ↗
• MalfunctionJul 31, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A LOBECTOMY, THE DEVICE PARTIALLY FIRED. THE SAME ISSUE OCCURRED ON THE SECOND SET OF MANUAL STAPLERS. A THIRD HANDLE AND RELOAD WERE USED TO RESECT AND RE-STAPLE THE TISSUE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674534 ↗
• MalfunctionJul 31, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A LOBECTOMY, THE DEVICE PARTIALLY FIRED. THE SAME ISSUE OCCURRED ON THE SECOND SET OF MANUAL STAPLERS. A THIRD HANDLE AND RELOAD WERE USED TO RESECT AND RE-STAPLE THE TISSUE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674366 ↗
• MalfunctionJul 28, 2025Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A LUNG VOLUME REDUCTION SURGERY, PRIOR TO USE, THERE WERE LOADING ISSUES WITH THE RELOAD WHEN THE SCRUB NURSE LOADED THE RELOAD TOO QUICKLY AND INCORRECTLY, CAUSING DAMAGE TO BOTH RELOADS AND THE ADAPTER. THE DEVICE WAS REPLACED WITH ANEW ADAPTER AND RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628897 ↗
• MalfunctionJul 3, 2025Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC (VATS) PULMONARY SEGMENTECTOMY, ON THE PULMONARY PARENCHYMA, ONLY ABOUT 2/3 OF THE CARTRIDGE COULD BE FIRED AND SEPARATED. A DIFFERENT TYPE OF RELOAD WAS USED TO CONTINUE THE RESECTION WHERE THE FIRST FIRING HAD STOPPED. IT WAS ALSO NOTED THAT THERE WAS A LEAK WHEN A LEAK TEST WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396714 ↗
• InjuryJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A PNEUMOTHORAX SINGLE-PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), PATIENT COUGHED UP BLOODY SPUTUM AND FOUND ABOUT THREE STAPLES IN IT ABOUT TWO WEEKS AFTER SURGERY. THE STAPLES THAT WERE COUGHED UP WERE NEATLY FORMED INTO TYPE B STAPLES. IT WAS NOTED THAT TWO RELOADS WERE USED AND HAD AN ISSUE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22324860 ↗
• MalfunctionJun 16, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A LUNG VOLUME REDUCTION SURGERY, THE DEVICE INDICATED A TISSUE THICKNESS LEVEL OF 2, SUGGESTING MODERATELY THICK TISSUE. THE STAPLER ABRUPTLY STOPPED HALFWAY THROUGH THE FIRING SEQUENCE. THE SURGEON REQUIRED THREE DIFFERENT STAPLERS TO FULLY TRANSECT THE TISSUE, WHICH EXTENDED THE SURGICAL TIME BY OVER 10 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213664 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC WEDGE RESECTION OF THE LUNG, AFTER THE NURSE LOADED THE HANDLE WITH THE RELOAD FOR THE SURGEON, THE RELOAD MAGAZINE FELL OFF THE HANDLE. A SECOND RELOAD WAS LOADED INTO THE SAME HANDLE. THE SURGEON PLACED THE FULLY ARTICULATED RELOAD ON THE LUNG TISSUE. THE GREEN BUTTON WAS PRESSED, AND THE INSTRUMENT WAS FULLY FIRED, AND THE STAPLES WERE PLACED IN THE TISSUE. THEN, THE BLACK RETRACTION BUTTON COULD NOT BE RETRACTED TO OPEN THE INSTRUMENT. THE JAWS LOCKED AND COULD NOT BE REMOVED FROM THE TISSUE. THE SURGICAL PROCEDURE WAS CONVERTED INTO AN OPEN SURGERY, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 60 MINUTES. THE SURGEON PLACED ANOTHER STAPLER WITH A 45 MM PURPLE LOADING UNIT DISTAL TO THE BLOCKED LOADING UNIT AND THEN RELEASED THE INSTRUMENT. THE BLOCKED MAGAZINE WAS THEN REMOVED FROM THE SITE. THE INCISION HAD TO BE WIDENED CONSIDERABLY IN THE THORACIC RE GION.

  Patient problems: Insufficient Information

  MAUDE report 22056039 ↗
• InjuryMay 20, 2025Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC WEDGE RESECTION OF THE LUNG, AFTER THE NURSE LOADED THE HANDLE WITH THE RELOAD FOR THE SURGEON, THE RELOAD MAGAZINE FELL OFF THE HANDLE. A SECOND RELOAD WAS LOADED INTO THE SAME HANDLE. THE SURGEON PLACED THE FULLY ARTICULATED RELOAD ON THE LUNG TISSUE. THE GREEN BUTTON WAS PRESSED, AND THE INSTRUMENT WAS FULLY FIRED, AND THE STAPLES WERE PLACED IN THE TISSUE. THEN, THE BLACK RETRACTION BUTTON COULD NOT BE RETRACTED TO OPEN THE INSTRUMENT. THE JAWS LOCKED AND COULD NOT BE REMOVED FROM THE TISSUE. THE SURGICAL PROCEDURE WAS CONVERTED INTO AN OPEN SURGERY, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 60 MINUTES. THE SURGEON PLACED ANOTHER STAPLER WITH A 45 MM PURPLE LOADING UNIT DISTAL TO THE BLOCKED LOADING UNIT AND THEN RELEASED THE INSTRUMENT. THE BLOCKED MAGAZINE WAS THEN REMOVED FROM THE SITE. THE INCISION HAD TO BE WIDENED CONSIDERABLY IN THE THORACIC REGION.

  Patient problems: Laceration(s)

  MAUDE report 22056016 ↗
• MalfunctionMay 1, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE COMPLETELY TO THE DISTAL END, RESULTING IN A PARTIAL FIRE. ONLY THE HANDLE WAS REPLACED WITH A NEW UNIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944673 ↗
• MalfunctionApr 15, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLON RESECTION WITH ROBOT SUPPORT, IN SIDE-TO-SIDE ANASTOMOSIS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE DEVICE DID NOT FIRE AT ALL. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21844916 ↗
• MalfunctionApr 3, 2025Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, DURING PULMONARY RESECTION WHEN USING THE DEVICE, IT ARTICULATED SIGNIFICANTLY AND UNINTENTIONALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767097 ↗
• MalfunctionMar 18, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, DURING RECTAL RESECTION, WHEN THE REINFORCE CARTRIDGE, RESECTION WAS DONE BUT AFTER ADVANCING 1-2 CENTIMETERS IT RETREATED ON ITS OWN. THE SAME THING HAPPENED TWO MORE TIMES TO BOTH REINFORCE CARTRIDGE. AFTER THAT, RESECTED IT WITH A REGULAR RELOAD. THAT ONE ALSO HAD STRANGE BEHAVIOR. AFTER THAT, USED ANOTHER RELOAD AND WAS ABLE TO COMPLETELY RESECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635651 ↗
• MalfunctionFeb 5, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN CREATING A GASTRIC POUCH, WHEN FIRING, THE RELOAD WAS BROKEN AS IT HAD FIRING ISSUE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313454 ↗
• MalfunctionFeb 4, 2025Break; Material Rupture; Misfire; Separation Failure; Break; Material Rupture; Misfire; Separation Failure

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT LUNG LOBECTOMY, THE SURGEON TRIED TO RELEASE THE REINFORCEMENT MATERIAL FROM THE TISSUE BY FIRING INTO THE LUNG PARENCHYMA, BUT THE REINFORCEMENT MATERIAL DID NOT SEPARATE FROM THE TISSUE, AND IT STARTED TO TEAR IT OFF. THE RELEASE STATUS COULD NOT BE CONFIRMED UNDER A THORASCOPE. NO INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305444 ↗
• MalfunctionDec 30, 2024Break; Component or Accessory Incompatibility; Material Twisted/Bent; Break; Component or Accessory Incompatibility; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING A PARTIAL PULMONARY RESECTION PROCEDURE, PRIOR TO USE IN THE PATIENT. THERE WAS LOADING PROBLEM WITH THE DEVICE, AFTER CONNECTION, THE CARTRIDGE WAS BENT AND THE HANDLE AND RELOAD CONNECTION PART WERE BROKEN (CARTRIDGE PART). TO RESOLVE THE ISSUE, A NEW ULTRA HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033570 ↗
• MalfunctionDec 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, AN ABNORMAL SOUND HAD SOUNDED FROM THE DEVICE, AND IT FIRED PARTIALLY. IT WAS NOTED THAT THE POWER HANDLE WAS RESTARTED TO CONFIRM THE ISSUE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904054 ↗
• MalfunctionDec 5, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC BULLECTOMY, WHEN THE 1ST RELOAD WAS FIRED IN THE LUNG PARENCHYMA, IT STOPPED MOVING IN THE MIDDLE AND THEN RETURNED ON ITS OWN. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857137 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173270. One submission often covers many models, so check the product and lot details in each record.

• Z-1891-2024 · Apr 15, 2024 · Open, Classified
  Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anas
• Z-1419-2021 · Mar 23, 2021 · Terminated
  Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic,