Tri-Staple 2.0 SIG45CTAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521543706), received between Apr 19, 2018 and Sep 21, 2026 — classified as 9 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (15 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847345 ↗
• MalfunctionSep 21, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847330 ↗
• MalfunctionMar 31, 2026Failure to Cut

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE STAPLED BUT DID NOT CUT. THE TISSUE WAS CUT WITH SCISSORS TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746732 ↗
• MalfunctionDec 2, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LEFT LOBE LIVER RESECTION, SPECIFICALLY IN THE GLISSON¿S CAPSULE, THERE WAS AN INCOMPLETE STAPLE FORMATION WITH THE TWO RELOADS. ADDITIONAL SUTURING WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23694720 ↗
• MalfunctionDec 2, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LEFT LOBE LIVER RESECTION, SPECIFICALLY IN THE GLISSON¿S CAPSULE, THERE WAS AN INCOMPLETE STAPLE FORMATION WITH THE TWO RELOADS. ADDITIONAL SUTURING WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23694614 ↗
• MalfunctionNov 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOT ESOPHAGEAL RESECTION FOR CHEST AND HAND-ASSISTED LAPAROSCOPIC SURGERY (HALS) FOR ABDOMEN, WHILE ON AZYGOS VEIN, THERE WAS STRESS THAT IMPEDES JAW OPENING AND CLOSING, LOCATED AT THE BASE OF THE JAW (AROUND THE JOINT AREA). ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642170 ↗
• MalfunctionJul 3, 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 AN OPEN WHIPPLE PROCEDURE DURING RESECTION OF THE HEPATIC ARTERY, THE STAPLES DID NOT FORM. THE STAPLE LINE ON THE HEPATIC ARTERY SUBSEQUENTLY FELL APART, RESULTING IN BLEEDING FROM THE HEPATIC ARTERY STAPLE LINE. SURGICAL REPAIR OF THE HEPATIC ARTERY WAS DONE USING A SUTURE.

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

  MAUDE report 22394017 ↗
• InjuryJul 12, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RIGHT LOWER PULMONARY VEIN RESECTION FOR THORACOSCOPIC RIGHT LOWER LOBECTOMY, THE RIGHT SIDE (ERASION SIDE) IN THE DIRECTION OF STAPLE PROGRESSION WAS SUCCESSFULLY STAPLED, BUT THE LEFT SIDE (CENTRAL SIDE) WAS NOT STAPLED, LEADING TO CUT-END BLEEDING. THERE WAS 2000 CC OF BLOOD LOSS FROM THE CUT END, THE HEART RATE DROPPED TO 30, AND WE ALMOST HAD A CARDIAC ARREST. THE INCISION WAS WIDENED FROM 4 CM TO 20 CM, AND THE BLEEDING WAS STOPPED WITH A FINGER. A CARDIOVASCULAR SURGEON PERFORMED THE SUTURES. AFTER THAT, A CARDIOVASCULAR SURGEON THEN ENTERS THE OPERATING ROOM (OP), CLAMPS THE CUT END WITH FORCEPS, AND LIGATES IT. AFTER COMPLETING THE OPERATION, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND WAS CURRENTLY RECOVERING. HOSPITALIZATION WAS EXTENDED. THE PATIENT RECOVERED SAFELY AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19735682 ↗
• MalfunctionFeb 13, 2024Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN (THORACOTOMY) LOBECTOMY PROCEDURE, AT THE TIME OF RESECTING THE PULMONARY ARTERY, FIRING WAS ATTEMPTED. HOWEVER, IT COULD NOT BE DONE. WHEN THE DISPLAY WAS CHECKED, 0 TIMES WAS DISPLAYED. A NEW RELOAD WAS USED WITH THE SAME POWERED DEVICES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699762 ↗
• InjuryJan 1, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC PULMONARY SEGMENTECTOMY, WHEN THE PULMONARY ARTERY WAS BEING PROCESSED, FIRING WAS PERFORMED AND AN ATTEMPT WAS MADE TO OPEN THE CARTRIDGE, BUT IT COULD NO LONGER BE OPENED HALFWAY THROUGH; A BLEEDING OCCURRED. THORACOTOMY WAS PERFORMED, THE BLOOD VESSEL WAS CLAMPED, AND IT WAS PROCESSED WITH LIGATION. THE PULMONARY ARTERY WAS DAMAGED BY MORE THAN ONE INCH AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE PATIENT WAS CURRENTLY UNDER OBSERVATION.

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

  MAUDE report 18423109 ↗
• MalfunctionSep 25, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A ROBOT-ASSISTED LAPAROSCOPIC PANCREATECTOMY/SPLENECTOMY, DURING BEDSIDE STAPLING, THE STAPLES WERE MA LFORMED AND THE STAPLE LINE WAS NOT SECURE. A CLIP APPLIER WAS USED TO SECURE THE ARTERY.

  Patient problems: Tissue Breakdown

  MAUDE report 17809166 ↗
• MalfunctionMar 17, 2023Misfire; Failure to Fire; Component or Accessory Incompatibility; Human-Device Interface Problem; Misfire; Failure to Fire; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, DURING VASCULAR RESECTION, THE CARTRIDGE COULD NOT BE LOADED PROPERLY. AN APPROACH WAS MADE, BUT THE DEVICE COULD NOT BE FIRED. A NEW CARTRIDGE WAS USED, BUT THE CARTRIDGE DID NOT COME OFF EITHER. THE SURGEON REPLACED BOTH THE HANDLE AND RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED. THE ADAPTER WAS DAMAGED AND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564681 ↗
• MalfunctionJan 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THE SURGEON APPROACHED THE BLOOD VESSEL, CLOSED THE JAWS, AND PRESSED THE GREEN BUTTON, BUT THE HANDLE COULD NOT BE SQUEEZED AND FIRING COULD NOT BE PERFORMED. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140199 ↗
• MalfunctionNov 4, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, WHEN THE LEFT PULMONARY ARTERY A3 SEGMENT VESSEL WAS APPROACHED AND ATTEMPTED TO FIRE THE NEEDLE BUT WAS UNABLE TO, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, AND THE HANDLE WAS GRIPPED. THE STATUS OF LCD SCREEN AT THAT TIME WAS CHECKED, AND THE RESPONSE WAS THAT STAFF HAD NOT SEEN IT, UNCLEAR IF THE CARTRIDGE WAS RECOGNIZED OR WHETHER THE CARTRIDGE WAS ALREADY PRE-FIRING. THE CARTRIDGE WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726573 ↗
• MalfunctionOct 29, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY LEFT UPPER LOBECTOMY, WHILE THE STAPLER AND LOAD WERE PLACED AROUND A BRANCH OF THE PULMONARY ARTERY, AND UPON ATTEMPTED FIRING, THE SURGEONS WERE UNABLE TO MOVE OR WORK THE STAPLER DUE TO A PART SEIZING OR BECOMING STUCK. WHEN REMOVED, THERE WAS NO APPARENT HARM TO THE ARTERY. THE STAPLER AND LOAD WERE REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694744 ↗
• InjuryJun 16, 2022Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON AN OPEN DISTAL PANCREATECTOMY, WHILE IN THE SUPERIOR MESENTERIC ARTERY, THE DEVICE FIRED WITH NO ISSUES BUT WHEN THE SURGEON RELEASED THE DEVICE FROM THE VESSEL AFTER FIRING, IT WAS DISCOVERED THAT THE DEVICE MISFIRED. THE VESSEL WAS DAMAGED AND THERE WAS BLEEDING. THE PATIENT LOST 300CC TO 500CC OF BLOOD. THE BLEEDING WAS CONTROLLED. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OF MORE. THE PATIENT STAY HAS ALSO BEEN EXTENDED. THE PATIENT IS STILL IN THE HOSPITAL. THE SURGEON STATED THAT THE PATIENT IS NOT DOING WELL..

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14716984 ↗
• InjuryJun 16, 2022Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE IN SPLENIC ARTERY IN A LAPAROSCOPIC SPLENECTOMY, THE DEVICE MISFIRED AND SURGEON HAD TO CONVERT PROCEDURE FROM LAPAROSCOPIC TO OPEN. PATIENT HAD UNEXPECTED TISSUE LOSS AND DAMAGE DUE TO DEVICE ISSUE. SURGICAL TIME WAS EXTENDED BY 100 MINUTES. BLOOD LOSS OF MORE THAN 500CC OR MORE WAS ALSO REPORTED THAT REQUIRED BLOOD TRANSFUSION. EXTENDED INCISION ALSO OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14712668 ↗
• InjuryMay 6, 2022Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ESOPHAGECTOMY, IT WAS ATTEMPTED TO BE USED IN RESECTING THE BLOOD VESSEL AROUND THE STOMACH, BUT FIRING COULD NOT BE PERFORMED. THE JAWS OF THE DEVICE LOCKED ON TISSUE. WHEN THE RELOAD WAS LOADED AND THE BLOOD VESSEL WAS CLAMPED WITH JAWS, THE DISPLAY OF THE HANDLE WAS FOUND TO BECOME ZONE 3, AND THE GREEN LAMP DID NOT ILLUMINATE. IT WAS NOT A TISSUE THAT WAS NORMALLY THICK ENOUGH TO BECOME ZONE3, SO IT WAS CHECKED IF ANY FOREIGN OBJECT WAS CLAMPED, BUT IT WAS NOT CLAMPED. AFTER A WHILE, THE GREEN LAMP DID NOT ILLUMINATE, SO THE USE OF DEVICE WAS DISCONTINUED, THE TARGET BLOOD VESSEL WAS LIGATED WITH SUTURE. SUBSEQUENTLY, ANOTHER CARTRIDGE (60 PURPLE) WAS LOADED INTO THE HANDLE AND USED DURING THE SAME PROCEDURE, BUT IT COULD BE USED WITHOUT ANY PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14307937 ↗
• MalfunctionMar 31, 2022Device Displays Incorrect Message; Failure to Fire; Insufficient Device Problem Information; Device Displays Incorrect Message; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A GASTRO INTESTINAL PROCEDURE, 3 RELOADS DID NOT FIRE AND SHOWED EXCESSIVE FORCE ERROR MESSAGE. OPENED A MANUAL HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 13965776 ↗
• MalfunctionSep 29, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN ABDOMINAL HEPATECTOMY, WHEN AN ATTEMPT WAS MADE TO RESECT THE HEPATIC VEIN WITH RELOAD, BOTH STAPLE AND KNIFE DID NOT ADVANCE EVEN WHEN SQUEEZED. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547470 ↗
• MalfunctionFeb 10, 2021Device Displays Incorrect Message; Human-Device Interface Problem; Device Displays Incorrect Message; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT LOBECTOMY, WHEN CLAMPING THE BLOOD VESSEL IN ORDER TO RESECT IT, THE HANDLE DISPLAY SHOWED 3, OPENED THE JAWS AND CLAMPED THE BLOOD VESSEL FROM ANOTHER DIRECTION AGAIN, BUT THE GREEN LAMP COULD NOT ILLUMINATE AND THE DISPLAY SHOWED THAT FIRING HAD BEEN ALREADY COMPLETED. ZERO ON CARTRIDGE PART AND NORMAL GREEN MARKS ON THE OTHERS. THE ANGLE WAS SLIGHTLY ARTICULATED TO THE LEFT UNTIL IT WAS COMPLETELY OPEN. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307005 ↗
• MalfunctionSep 17, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LUNG RESECTION PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT COULD NOT SQUEEZE THE HANDLE. HENCE, THE STAPLE WOULD NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10547962 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A VIDEO ASSISTED THORASCOPIC RIGHT LOWER LOBECTOMY, THE PATIENT HAD TO RETURN TO THEATRE 6 HOURS AFTER SURGERY TO INVESTIGATE 1 LITRE OF BLOOD LOSS IN CHEST DRAIN AND MANAGEMENT OF BLEEDING. THE PULMONARY ARTERY WAS FOUND TO HAVE PULSATILE BLEEDING THROUGH THE CENTER OF VESSEL. THE BLEEDING WAS REPORTED TO BE A SINGLE SPURT OF BLOOD COMING THROUGH THE CENTER OF THE STAPLE LINE. A CLIP WAS PLACED ON THE ARTERY TO CONTROL THE BLEEDING. IT WAS REPORTED THAT THE SURGICAL TIME WAS EXTENDED BY ONE HOUR. NO FURTHER EVENTS HAVE BEEN REPORTED AND PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 10412866 ↗
• MalfunctionJul 1, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER MISFIRED.

  Patient problems: No Information

  MAUDE report 10221191 ↗
• MalfunctionJun 10, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY, AFTER FIRING, A YELLOW PLASTIC PIECE FELL ON A PATIENT'S CAVITY AND WAS RETRIEVED. SINCE IT WAS UNCLEAR IN WHICH THE PIECE FELL FROM, ALL THE CARTRIDGES WERE REMOVED IN THE SURGICAL FIELD. IT WAS ALSO NOTED THAT A YELLOW TAB OF ONE OF THE COLLECTED CARTRIDGES WAS HANGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136770 ↗

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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• 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