Signia SIGSDL45CTVTRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521741843), received between Aug 31, 2020 and Aug 12, 2026 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 25, 2025Class IIOpen, Classified

   A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

   Z-0485-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 4, 2021Class IITerminated

   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-1383-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50221689 ↗
• MalfunctionAug 12, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50221654 ↗
• MalfunctionFeb 16, 2026Failure to Fire

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE INSTRUMENT DID NOT FIRE AND THE HANDLE COULD NOT BE SQUEEZED, ALTHOUGH THE GREEN SAFETY BUTTON WAS ABLE TO BE PRESSED. THE DEVICE WAS REPLACED BY OPENING A NEW HANDLE AND RELOAD TO FIRE.

  Patient problems: Insufficient Information

  MAUDE report 24358988 ↗
• MalfunctionJul 28, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A ZENKER¿S DIVERTICULUM, THE SURGEON FELT RESISTANCE WHEN FIRING AND BELIEVED THE FIRING SEQUENCE WAS COMPLETE, BUT TWO DIFFERENT 45MM RELOADS APPEARED TO HAVE ONLY FIRED TO ABOUT 30MM. A RESECT AND RE-STAPLE INTERVENTION WAS PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22634476 ↗
• MalfunctionJul 28, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A ZENKER¿S DIVERTICULUM, THE SURGEON FELT RESISTANCE WHEN FIRING AND BELIEVED THE FIRING SEQUENCE WAS COMPLETE, BUT TWO DIFFERENT 45MM RELOADS APPEARED TO HAVE ONLY FIRED TO ABOUT 30MM. A RESECT AND RE-STAPLE INTERVENTION WAS PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22628157 ↗
• MalfunctionJul 23, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY PROCEDURE, THE HANDLE AND RELOAD EXPERIENCED PARTIAL FIRING, WITH FIRING STOPPING AFTER APPROXIMATELY THREE OR FOUR ROWS OF STAPLES. THE KNIFE BLADE WAS SUCCESSFULLY RETRACTED, AND THE ISSUE WAS RESOLVED BY REPLACING BOTH THE HANDLE AND THE CARTRIDGE WITH NEW PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574791 ↗
• MalfunctionJun 30, 2025Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE PROCEDURE, INTRAOPERATIVELY, THE DOCTOR TRIED TO STAPLE AN ARTERY, BUT THE RELOAD WAS NOT EFFECTIVE, LEAVING THE ARTERY OPEN IN PARTS, CAUSING BLEEDING DURING THE SURGERY. A SECOND LOAD WAS USED AND THE PROBLEM OF THE LOAD NOT BEING STAPLED REPEATED. IT WAS NECESSARY TO USED ANOTHER RELOAD TO RESOLVE THE PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367464 ↗
• MalfunctionJun 30, 2025Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE PROCEDURE, INTRAOPERATIVELY, THE DOCTOR TRIED TO STAPLE AN ARTERY, BUT THE RELOAD WAS NOT EFFECTIVE, LEAVING THE ARTERY OPEN IN PARTS, CAUSING BLEEDING DURING THE SURGERY. A SECOND LOAD WAS USED AND THE PROBLEM OF THE LOAD NOT BEING STAPLED REPEATED. IT WAS NECESSARY TO USED ANOTHER RELOAD TO RESOLVE THE PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367416 ↗
• InjurySep 24, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT, AFTER USAGE OF THE RELOAD ON THE RENAL ARTERY AND VEIN, THE SURGEON RELEASED THE KIDNEY FROM THE DONOR; UNFORTUNATELY, THERE WAS MASSIVE BLEEDING FROM THE ARTERY AT THE STAPLE LINE. THE SURGEON NOTICED THAT DURING CLAMPING THE ARTERY AND AFTER PRESSING THE GREEN BUTTON TO START FIRING, THE ARTERY WAS STILL MOVING BETWEEN THE JAWS OF THE CARTILAGE AND NOT COMPRESSED PROPERLY BETWEEN THE JAWS. THE PROCEDURE WAS CONVERTED INTO AN OPEN SURGERY TO CONTROL THE BLEEDING, AND HAND SEWING WAS DONE WITH THE APPLICATION OF A HEMOCLIP. ALSO, THE PROCEDURE WAS EXTENDED BY NOT LESS THAN SIX HOURS. IT WAS ALSO NOTED THAT THE SURGEON NOTICED THE PART OF THE ARTERY HAD STAPLES AND AT THE CORNER OF THE ARTERY IT DID NOT HAVE STAPLES, AND THIS WAS THE SIDE OF BLEEDING, AND THE STAPLING WAS INTACT AT THE SPECIMEN SIDE. THE PATIENT WAS SECURED AFTER CONTROLLING THE BLEEDING BUT PUSHED FOR ICU FOR CLOSE MONITORING.

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

  MAUDE report 20295242 ↗
• MalfunctionSep 16, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LIVING DONOR NEPHRECTOMY, THE SURGEON PLACED THE RENAL ARTERY IN THE JAWS AND CLOSED THE GREEN BUTTON AND WAS DEPLOYED TO FIRE BUT IT APPEARED THAT THE JAWS WERE NOT COMPLETELY CLOSED. THE DEVICE WAS TAKEN OUT OF THE FIRING MODE AND THE RELOAD WAS TESTED OUTSIDE THE PATIENT. THE RELOAD CLOSED COMPLETELY. THE USER REPEATED THE PROCESS AND THE JAWS WERE NOT COMPLETELY CLOSED BUT AS THE RELOAD BEGAN TO FIRE THE JAWS CLOSED AS THE BLADE MOVED DOWN THE RELOAD. AFTER FIRING, THE VESSEL BEGAN TO BLEED. THE DOCTOR TEMPORARILY STOPPED THE BLEEDING WITH COMPRESSION. A SECOND RELOAD WAS FIRED ON THE RENAL VEIN WITH THE SAME LOT NUMBER TO FREE THE KIDNEY AND REMOVE. THE OPERATOR THEN WENT IN WITH A 5 MM CLIP AND SUTURED TO STOP THE BLEEDING. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS LUMPECTOMY AND REMOVAL OF BILATERAL OVIDUCTS.

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

  MAUDE report 20230977 ↗
• MalfunctionSep 10, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LIVING DONOR NEPHRECTOMY, THE SURGEON PLACED THE RENAL ARTERY IN THE JAWS AND CLOSED THE GREEN BUTTON AND WAS DEPLOYED TO FIRE BUT IT APPEARED THAT THE JAWS WERE NOT COMPLETELY CLOSED. THE DEVICE WAS TAKEN OUT OF THE FIRING MODE AND THE RELOAD WAS TESTED OUTSIDE THE PATIENT. THE RELOAD CLOSED COMPLETELY. THE USER REPEATED THE PROCESS AND THE JAWS WERE NOT COMPLETELY CLOSED BUT AS THE RELOAD BEGAN TO FIRE THE JAWS CLOSED AS THE BLADE MOVED DOWN THE RELOAD. AFTER FIRING, THE VESSEL BEGAN TO BLEED. THE DOCTOR TEMPORARILY STOPPED THE BLEEDING WITH COMPRESSION. A SECOND RELOAD WAS FIRED ON THE RENAL VEIN WITH THE SAME LOT NUMBER TO FREE THE KIDNEY AND REMOVE. THE OPERATOR THEN WENT IN WITH A 5 MM CLIP AND SUTURED TO STOP THE BLEEDING.

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

  MAUDE report 20182117 ↗
• MalfunctionJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, ON THE SMALLER LOWER RENAL POLE ARTERY, THE UPPER PORTION OF THE STAPLE LINE WAS OOZING WITH BLOOD AT THE TISSUE SITE. THE TOTAL BLOOD LOSS WAS 25 MILLILITERS. TWO CLIP APPLIERS WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19807924 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE TOTAL NEPHRECTOMY, THERE WAS NO BLEEDING AT THE TIME OF IMPLANTATION ON THE RENAL ARTERY AND RENAL VEIN. FOLLOWING THAT, THE SURGEON REPORTED THAT THE ARTERY WHICH HAD BEEN OCCLUDED WITH THE STAPLER, WAS BLEEDING PROFUSELY. THE PATIENT REQUIRED INTUBATION, HAD A BLOOD LOSS OF MORE THAN 500CC, THE INCISION WAS EXTENDED FOR MORE THAN ONE INCH, AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS CURRENTLY HAS BEEN EXTUBATED AND IS IN GOOD CONDITION.

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

  MAUDE report 19585585 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STAPLE LINE WAS RELEASED JUST AFTER STAPLING THE RENAL ARTERY OF THE LIVING KIDNEY DONOR. THE PATIENT EXPERIENCED BLOOD LOSS AND LONGER HOSPITAL STAY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. IT WAS ALSO MENTIONED THAT THERE WAS DELAYED RECOVERY OF GRAFT FUNCTION OF THE RECIPIENT.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17374953 ↗
• MalfunctionAug 10, 2022Adverse 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 CLINICAL STUDY, POST-OPERATIVELY OF A LUNG TRANSPLANT, STERILITY CULTURES OF LUNGS CAME BACK POSITIVE FOR METICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS AND CANDIDA LUSITANIAE PNEUMONIA. THE ISSUE RESULTED IN CONCOMITANT OR ADDITIONAL TREATMENT. THE PATIENT WAS GIVEN 2 GRAMS OF ANTIBIOTICS EVERY 8 HOURS UNTIL THE 13TH POST-OPERATIVE DAY. THE PATIENT¿S HOSPITALIZATION WAS ALSO EXTENDED UP TO 38 DAYS. IT WAS STATED THAT THE ADVERSE EVENT WAS CAUSALLY RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE.

  Patient problems: Insufficient Information; Pneumonia

  MAUDE report 15200859 ↗
• MalfunctionJul 22, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING STAPLING/TRANSECTING RENAL VEIN IN A HAND ASSISTED LAPAROSCOPIC RIGHT NEPHRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. THE DEVICE WAS NOT ABLE TO FIRE. THE SURGEON PULLED BACK ON BLACK LEVER ON TOP OF STAPLER AFTER STAPLER WOULD NOT FIRE AFTER PRESSING GREEN BUTTON, STATED THAT JAWS DID NOT OPEN FROM RENAL VASCULATURE. THE SURGEON CONTINUED TO PULL BACK ON BLACK LEVER ON TOP OF STAPLER, MANIPULATED STAPLER HANDLE, AND EVENTUALLY WAS ABLE TO REMOVED RELOAD FROM VASCULATURE WITHOUT SIGNS OF DAMAGE. THE SURGEON REPLACED THE HANDLE AND USED ANOTHER RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089506 ↗
• MalfunctionMay 17, 2022Self-Activation or Keying; Insufficient Device Problem Information; Self-Activation or Keying; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE PREPARING THE DEVICE, THE SHELL TRIGGERED THE DEVICE EVEN WHEN THE SAFETY WAS ON. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 14414425 ↗
• MalfunctionMay 16, 2022Self-Activation or Keying; Insufficient Device Problem Information; Self-Activation or Keying; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE FIRED WITH THE SAFETY ON. THE FIRING OCCURRED BY ONLY PRESSING DOWN UPON INSERTION IN THE ABDOMEN. THE SURGEON STOPPED USING THE DEVICE AND WAS SWITCHED OUT FOR AN ENTIRELY DIFFERENT STAPLER WITH ALL DIFFERENT COMPONENTS.

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

  MAUDE report 14413203 ↗
• InjuryFeb 3, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LEFT KIDNEY DONOR NEPHRECTOMY, WHILE STAPLING THE STAPLING OF ARTERY ORIGIN FROM AORTA, THERE WAS BLEEDING AFTER PLACEMENT OF SELECTIVE DORSAL RHIZOTOMY (SDR). THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE WHICH RESULTED IN A PULSATILE BLEEDING OF 500CC OR MORE. THE STAPLE LINE WAS FIXED WITH CLIPS AND SEALANT PATCH. THE TISSUE WAS DAMAGED. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE.

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

  MAUDE report 13446681 ↗
• MalfunctionNov 1, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER JAWS DID NOT CLOSE ALL OF THE WAY FOR THE RELOAD. THIS WAS OUTSIDE THE PATIENT ON A POWERED STAPLER WHEN THE TECHNICIAN WAS OPENING AND CLOSING THE JAWS BEFORE PASSING OFF THE STAPLER TO THE SURGEON. A DIFFERENT LOT NUMBER OF THE SAME RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12731366 ↗
• MalfunctionOct 29, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC KIDNEY DONOR PROCEDURE, THE STAPLER JAWS DID NOT CLOSE ALL OF THE WAY FOR THREE DIFFERENT RELOADS OF THE SAME LOT NUMBER. THIS WAS OUTSIDE THE PATIENT ON A POWERED STAPLER WHEN THE TECHNICIAN WAS OPENING AND CLOSING THE JAWS BEFORE PASSING OFF THE STAPLER TO THE SURGEON. A DIFFERENT LOT NUMBER OF THE SAME RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721086 ↗
• InjuryJun 23, 2021Unintended System Motion; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Unintended System Motion; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATO-SPLENECTOMY PROCEDURE, THE DEVICE ABLE TO FIRE BUT THERE WAS POOR STAPLE FORMATION RESULTING TO AN OOZING BLEEDING. THE RELOAD APPEARED TO WIGGLE LEFT TO RIGHT DURING FIRING; 3 MILLIMETER IN EITHER DIRECTION FROM CENTER. IN ADDITION, THE RELOAD WAS ALSO WIGGLING BACK AND FORTH A CENTIMETER IN BOTH DIRECTION WHILE FIRING. TO RESOLVE THE ISSUE THE SURGEON USED CLIP OVER THE MINIMAL OOZING THAT OCCURRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12050957 ↗
• MalfunctionMay 3, 2021Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, WHEN THE SURGEON CUT USING THE DEVICE ON A ROBOT-ASSISTED LAPAROSCOPIC ENDOSCOPIC PROCEDURE, THEY TRIED TO PULL THE BLACK RETURN KNOB AFTER FIRING BUT THE RESISTANCE WAS STRONG AND WAS NOT ABLE TO BE PULLED. AFTER TRYING SEVERAL TIMES AND PULLING WITH STRONG FORCE, THE BLACK KNOB WAS FINALLY PULLED BACK. THE DEVICE WAS USED IN A STATE WHERE IT WAS ARTICULATED TO THE LEFT AS MUCH AS POSSIBLE WITH REFERENCE TO THE CARTRIDGE SIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761353 ↗
• InjuryApr 19, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON AN OPEN LEFT LOBECTOMY, THE DEVICE WAS FIRED AT THE FIRING SPEED OF ZONE 2. WHEN THE JAWS WERE REMOVED FROM THE BLOOD VESSEL AFTER THE LIVER VEIN RESECTION, NO STAPLE WAS FOUND TO BE PLACED AT ALL. ONLY THE KNIFE ADVANCED AND BLEEDING WAS SEEN. SUTURING WAS PERFORMED ON THE LIVER VEIN AND STOPPED THE BLEEDING. THE BLOOD LOSS WAS 500CC OR MORE.

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

  MAUDE report 11690166 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DONOR NEPHRECTOMY PROCEDURE, THE STAPLE LINE IN RENAL ARTERY WAS COMPLETE AND STAPLES WERE FULLY FORMED, HOWEVER STAPLE LINE BLEEDING WAS EXPERIENCED WITH ESTIMATED BLOOD LOSS OF 300ML. CLIPS WERE USED TO CONTROL THE BLEEDING. THE SURGICAL TIME WAS EXTENDED BY 60 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11412602 ↗

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-1458-2024 · Feb 14, 2024 · Open, Classified
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• Z-1457-2024 · Feb 14, 2024 · Open, Classified
  Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• Z-1384-2021 · Mar 4, 2021 · Terminated
  Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
• 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