Signia SIGSDS30CTVTRecalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10884521741881), received between Jun 9, 2020 and Sep 29, 2026 — classified as 1 death, 31 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (37 reports).

2 FDA recall records name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K191070, K253657); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 14, 2024Open, Classified

   Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.

   Z-1457-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Mar 4, 2021Terminated

   Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

   Z-1384-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937333 ↗
• MalfunctionAug 12, 2026Retraction Problem; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224890 ↗
• MalfunctionAug 4, 2026Misfire; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132842 ↗
• MalfunctionMay 21, 2026Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, FOLLOWING A RELOAD, STAPLER FIRED STAPLES BUT WOULD NOT RELEASE THE TISSUE. FOLLOWING SEVERAL ATTEMPTS, THE SURGEON WAS UNABLE TO GET THE STAPLER TO RELEASE THE TISSUE. MANUAL RELEASE KEY WAS USED TO OPEN THE JAWS. STAPLE LINE APPEARED TO BE INTACT FOLLOWING MANUAL RELEASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238832 ↗
• MalfunctionMay 5, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN SETTING UP, WHILE CHECKING THE OPENING AND CLOSING DURING CONNECTION, THERE WAS DIFFICULTY OPENING THE JAW AND THE JAW WOULD NOT OPEN AT ALL. THE PRODUCT WAS REPLACED WITH ANOTHER NEW SIMILAR CARTRIDGE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THERE WAS STAPLING - INCOMPLETE RETRACTION. THE JAWS OF THE RELOAD WERE CLAMPED. THE I BEAM WAS SLIGHTLY ADVANCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086745 ↗
• MalfunctionMay 4, 2026

  FOLLOWING A RELOAD, STAPLER FIRED STAPLES BUT WOULD NOT RELEASE THE TISSUE. FOLLOWING SEVERAL ATTEMPTS, SURGEON WAS UNABLE TO GET THE STAPLER TO RELEASE THE TISSUE. MANUAL RELEASE KEY WAS USED TO OPEN THE JAWS. STAPLE LINE APPEARED TO BE INTACT FOLLOWING MANUAL RELEASE.

  Patient problems: Insufficient Information

  MAUDE report 25067404 ↗
• MalfunctionApr 1, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY TO CUT THE APPENDIX, THE RELOAD FIRED COMPLETELY BUT WOULD NOT RETRACT THE KNIFE BLADE. STAFF REPORTEDLY CRANKED THE SCREWDRIVER THE WRONG WAY FOR A LONG TIME WHILE TRYING TO DETERMINE WHAT TO DO, AND THE PROCEDURE WAS EXTENDED BY ABOUT 30 MINUTES. A MANUAL RETRACTION TOOL WAS 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 24760827 ↗
• MalfunctionMar 19, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING THE THORACIC SEGMENTECTOMY, AFTER FIRING ON THE LUNG ARTERY, THE STAPLER LOCKED ON TISSUE AND COULD NOT BE REMOVED. THE SURGEON WAS ABLE TO OPEN THE STAPLER AFTER STRUGGLING, AND THE HANDLE WAS REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644411 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE PREPARING THE RELOAD, IT WOULD NOT FIT AND KEPT COMING OFF. TO RESOLVE THE ISSUE, A HANDLE AND WHITE RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378928 ↗
• MalfunctionJan 29, 2026Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THE VIDEO ASSISTED THORACOSCOPIC SURGERY, THE JAWS DID NOT OPEN AFTER STAPLING THE BLOOD VESSEL. A DDITIONALLY, AFTER WAITING FOR A SHORT TIME, THE JAW EVENTUALLY OPENED SO NO TREATMENT INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218208 ↗
• MalfunctionJan 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PULMONARY LOBECTOMY USING THE POWERED STAPLER, AFTER PRESSING THE GREEN BUTTON, THE DEVICE DID NOT FIRE DESPITE ALL PREPARATIONS BEING COMPLETED. THE RELOAD WAS REPLACED WITH ANOTHER SMALL DIAMETER RELOAD, WHICH WAS FIRED WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094902 ↗
• MalfunctionJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LIVING TRANSPLANT PROCEDURE¿SPECIFICALLY DURING THE RESECTION OF THE DONOR'S RENAL ARTERY¿THE SUTURE LINE BLED, REQUIRING THE APPLICATION OF ADDITIONAL REFILLS AND CLIPS. PROLONGED SURGICAL TIME WAS NOTED BUT NOT MORE THAN 30 MINUTES. ADDITIONALLY, THE HANDLE MADE A NOISE WHEN ROTATED. TO ADDRESS THE SITUATION, THE SURGICAL TEAM PERFORMED RESECTION AND RE-STAPLING.

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

  MAUDE report 24034799 ↗
• MalfunctionDec 30, 2025Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY, WHILE ON BLOOD VESSEL, THE ANGLE OF THE JAW WAS ADJUSTED, BUT IT WAS NOT AT THE DESIRED ANGLE, SO IT WAS REMOVED ONCE. THE ANGLE OF THE JAW WAS ADJUSTED OUTSIDE THE SURGICAL FIELD, AND AN ATTEMPT WAS MADE TO CLOSE THE JAW, BUT IT DID NOT CLOSE. A NEW RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926209 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RELOAD WAS USED ON ONE OF THE BRANCHES OF THE PULMONARY ARTERY. AFTER FIRING, STAPLE LINE BLEEDING WAS OBSERVED, AND TWO ADDITIONAL METAL CLIPS WERE REQUIRED TO ACHIEVE HEMOSTASIS. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 30 TO 45 MINUTES, AND THE PATIENT REQUIRED REOPERATION FOR HEMOSTASIS. THERE WAS BLOOD LOSS OF LESS THAN 500CC.

  Patient problems: Tissue Breakdown

  MAUDE report 23691847 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTOPERATIVE VIDEO-ASSISTED THORACOSCOPIC SURGERY, EXCESSIVE AND SEVERE STAPLE LINE BLEEDING OCCURRED AT THE ARTERIAL BRANCH OF SEGMENT 6 OF THE LEFT LUNG. THE ISSUE WAS IDENTIFIED WHILE THE PATIENT WAS STILL IN THE OPERATING ROOM DURING THE EXTUBATION. THE PATIENT BEGAN WAKING UP QUICKLY, PROMPTING THE SURGICAL TEAM TO PUT THE PATIENT BACK TO SLEEP TO ADDRESS THE BLEEDING. THE PROCEDURE WAS THEN CONVERTED FROM THORACOSCOPIC TO OPEN SURGERY. AN ADDITIONAL SURGICAL OPERATION WAS REQUIRED TO CONTROL THE BLEEDING, DURING WHICH THE SURGEON MANUALLY SUTURED AND CLOSE THE AFFECTED ARTERY. AS A RESULT, THE SURGICAL TIME WAS EXTENDED BY ONE HOUR. IT WAS NOTED THAT THE PATIENT HAD BLOOD LOSS OF 2000-2500CC AND REQUIRED BLOOD TRANSFUSION.

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

  MAUDE report 23344427 ↗
• MalfunctionSep 19, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING THE ROBOTIC LAPAROSCOPIC THORACIC WEDGE RESECTION, WHILE STAPLING THE PULMONARY ARTERY, THE RELOAD ARTICULATED/STRAIGHTENED DURING FIRING. IT WAS NOTED THAT THE RELOAD ARTICULATED IN ONE DIRECTION WHILE THE KNIFE BLADE WAS ON RETRACTION. NO INTERVENTION WAS DONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096274 ↗
• MalfunctionAug 27, 2025Failure to Fire; Difficult to Open or Close; Expulsion; Failure to Fire; Difficult to Open or Close; Expulsion

  ACCORDING TO THE REPORTER, DURING AN UPPER LOBE RESECTION, THERE WAS NO ISSUE DURING THE FIRST AND SECOND FIRINGS, BUT AT THE TIME OF LOADING FOR THE THIRD FIRING, THE SLIGHT OPENING AND CLOSING DID NOT OPERATE ACCURATELY, AND THE OPENING AND CLOSING OPERATION WAS STIFF. AFTER COMPLETING THE OPENING AND CLOSING CHECK OF THE JAWS, THE BLOOD VESSEL WAS APPROACHED AND FIRING WAS ATTEMPTED, BUT FIRING COULD NOT BE PERFORMED. THE TIP SIDE OF THE CARTRIDGE WAS OPENED AND COLLECTED; THE HANDLE AND CARTRIDGE WERE BOTH REPLACED, AND WHEN AN APPROACH WAS MADE AGAIN, THE RESECTION WAS PERFORMED WITHOUT ANY PROBLEM. AFTER THE SURGERY, THE CARTRIDGE WAS CHECKED, AND A SLIGHT/FEW PRE-FIRINGS WERE FOUND AT THE PROXIMAL SIDE OF THE CHANNEL JAWS.

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

  MAUDE report 22903464 ↗
• MalfunctionJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A RIGHT UPPER SEGMENTECTOMY, THE POWERED STAPLER WAS FIRED AND RETRACED WITHOUT AN ISSUE. HOWEVER, THE STAPLE LINE HAD A SMALL SPURTING BLEED. THE BLEEDING WAS RESOLVED BY USING A HORIZONTAL CLIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22636740 ↗
• MalfunctionJul 21, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LIVING DONOR KIDNEY TRANSPLANTATION, AT THE TIME OF RENAL ARTERY RESECTION, AFTER THE FIRING WAS COMPLETED, THE JAW DID NOT OPEN. MOREOVER, THE JAW NATURALLY OPENED, AND IT WAS ABLE TO BE REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555707 ↗
• MalfunctionJul 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY CASE, THE RELOAD COULD NOT BE FIRED BY THE MANUAL STAPLER. THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. THE ISSUE WAS RESOLVED BY REPLACING THE RELOAD WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532683 ↗
• MalfunctionJul 16, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE DONOR NEPHRECTOMY, THE RELOAD WAS POSITIONED ONTO THE VEIN, CLAMPED, AND MOST OF THE STAPLES HAVE BEEN DEPLOYED AND RELEASED FROM THE STAPLER, HOWEVER, IN THE SECTION WHERE THE VEIN WAS, THE STAPLES WERE STILL IN THE JAWS OF THE STAPLE, FORMED BUT NOT RELEASED. THIS RESULTED IN THE VEIN BEGINNING TO SPURT BLOOD AS IT WAS NOT SEALED, AND THE DISTAL STAPLE LINE WAS INCOMPLETE. THE PROCEDURE WAS EXTENDED BY FIVE MINUTES. TO MANAGE THE BLEEDING, TWO HEMOLOCKS WERE PLACED ON THE VEIN TO SEAL IT AND ADDITIONAL RELOAD WAS USED TO COMPLETE THE CASE.

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

  MAUDE report 22527316 ↗
• MalfunctionJul 11, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING COULD NOT BE PERFORMED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477346 ↗
• DeathJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN CLAMPING A SEGMENT OF THE LEFT PULMONARY ARTERY (A1/3), BLEEDING OCCURRED AFTER REMOVAL OF THE MAGAZINE AT THE PROXIMAL CLAMP LINE, WHICH RAPIDLY INCREASED AND NECESSITATED AN EMERGENCY THORACOTOMY. DUE TO MASSIVE BLEEDING WITH CARDIAC ARREST, THE PATIENT DIED.

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

  MAUDE report 22466837 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A DONOR NEPHRECTOMY USING A POWERED STAPLER, THE RELOAD WAS ATTACHED BY THE NURSING TEAM, AND THE SURGEON PLACED IT ON THE ARTERY AND CLOSED THE JAWS AND WHEN ATTEMPTING TO REOPEN THEM FOR REPOSITIONING, THE JAWS WOULD NOT OPEN, CAUSING THE VESSEL TO BE STUCK AND DELAYING THE PROCEDURE BY FIVE MINUTES. THE VESSEL WAS EVENTUALLY RELEASED, AND A STAPLER FROM ANOTHER COMPANY WAS USED TO COMPLETE THE FIRING. A DIFFERENT RELOAD WAS LATER USED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446635 ↗
• MalfunctionJul 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DURING A PROCEDURE, USING A CURVE TIP RELOAD, THE MANUAL HANDLE DID NOT FIRE. THE HANDLE WAS ABLE TO BE SQUEEZED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22390766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191070, K253657. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2026 · Sep 25, 2025 · Open, Classified
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
• Z-0485-2026 · Sep 25, 2025 · Open, Classified
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
• Z-1458-2024 · Feb 14, 2024 · Open, Classified
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• Z-1385-2021 · Mar 4, 2021 · Terminated
  Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
• Z-1383-2021 · Mar 4, 2021 · Terminated
  Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT