Signia SIGSDS30CTVRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10884521741874), received between Apr 24, 2020 and Jan 13, 2026 — classified as 1 death, 20 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (17 reports).

1 FDA recall record name this device's identifier.

6 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 16, 2026.

Recalls naming this device

1. 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-1385-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN LIVER RESECTION, DURING VASCULAR TREATMENT, THE STAPLER WAS STUCK AFTER A SINGLE FIRING GRIP. THE FIRING WAS STOPPED, AND THE DEVICE WAS WITHDRAWN USING THE BLACK RETURN KNOB. IT WAS REPORTED THAT THE FIRING HAD BEEN PARTIALLY COMPLETED UP TO THE POINT WHERE THE HANDLE WAS GRIPPED. AFTERWARDS, A DIFFERENT CARTRIDGE WAS ATTACHED, THE FIRING WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054908 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, AFTER FIRING IN THE BLOOD VESSEL (A6), THERE WAS BLEEDING FROM THE BLOOD VESSEL. APPROXIMATELY 1,100 CC OF BLEEDING, AND IT WAS TRANSITIONED TO THORACOTOMY TO STOP THE BLEEDING. A MANUAL SUTURING WAS PERFORMED TO RESOLVE THE ISSUE.

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

  MAUDE report 23855257 ↗
• MalfunctionDec 17, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING A LOBECTOMY, THE INSTRUMENT DID NOT STAPLE, RESULTING IN THE STAPLE LINE NOT BEING COMPLETED ALONG THE ENTIRE LENGTH OF THE VESSEL. THE PROCEDURE WAS EXTENDED BY FORTY MINUTES. SUTURING WAS REQUIRED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23834857 ↗
• MalfunctionSep 3, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPY WITH MEDIASTINAL AND REGIONAL LYMPHADENECTOMY, A VASCULAR STAPLE LOAD WAS FIRED ON THE PATIENT. HOWEVER, BLEEDING OCCURRED AT THE END OF THE STAPLE LINE. UPON INSPECTION, IT WAS NOTED THAT THE STAPLES HAD NOT FIRED AND WERE STUCK IN THE LOAD. THE DOCTOR THEN PROCEEDED TO USE ANOTHER VASCULAR STAPLE ON A DIFFERENT VESSEL. WHILE THE LOAD FIRED, THE INNER SECTION DID NOT FIRE CORRECTLY, LEAVING STAPLES IN THE LOAD. THIS RESULTED IN BLEEDING, AND THE PATIENT LOST APPROXIMATELY 200 ML OF BLOOD.

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

  MAUDE report 22959678 ↗
• MalfunctionSep 3, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPY WITH MEDIASTINAL AND REGIONAL LYMPHADENECTOMY, A VASCULAR STAPLE LOAD WAS FIRED ON THE PATIENT. HOWEVER, BLEEDING OCCURRED AT THE END OF THE STAPLE LINE. UPON INSPECTION, IT WAS NOTED THAT THE STAPLES HAD NOT FIRED AND WERE STUCK IN THE LOAD. THE DOCTOR THEN PROCEEDED TO USE ANOTHER VASCULAR STAPLE ON A DIFFERENT VESSEL. WHILE THE LOAD FIRED, THE INNER SECTION DID NOT FIRE CORRECTLY, LEAVING STAPLES IN THE LOAD. THIS RESULTED IN BLEEDING, AND THE PATIENT LOST APPROXIMATELY 200 ML OF BLOOD.

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

  MAUDE report 22959528 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, STAPLE LINE BLEEDING WAS NOTED ON THE FOUR RELOADS AFTER FIRING. SUTURING AS A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE.

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

  MAUDE report 22739399 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, STAPLE LINE BLEEDING WAS NOTED ON THE FOUR RELOADS AFTER FIRING. SUTURING AS A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE.

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

  MAUDE report 22739039 ↗
• MalfunctionAug 6, 2025Entrapment of Device; Misfire

  FIRED A VASCULAR STAPLE LOAD ON THIS PATIENT, AND AT THE END OF THE STAPLE LINE IT BLED. WHEN INSPECTING THE LOAD IT APPEARS THE STAPLES DID NOT FIRE AND WERE STUCK IN THE LOAD. DR. PROCEEDED TO USE ANOTHER VASCULAR STAPLE ON A DIFFERENT VESSEL ON THE PATIENT. THE LOAD FIRED BUT THIS TIME THE SECTION ON THE INNER PART DID NOT FIRE CORRECTLY AND LEFT STAPLES IN THE LOAD. THIS CAUSED BLEEDING ON THE PT WHOM LOST ABOUT 200MLS FROM IT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22728232 ↗
• MalfunctionJul 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), WHEN IT WAS APPLIED TO A VESSEL WHEN TWO RELOADS DID NOT FIRE AND THE PUSHERS DID NOT EXTEND. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES. NUMEROUS CLIPS WERE UTILIZED TO CONTROL BLEEDING THAT OCCURRED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22595218 ↗
• MalfunctionJul 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), WHEN IT WAS APPLIED TO A VESSEL WHEN TWO RELOADS DID NOT FIRE AND THE PUSHERS DID NOT EXTEND. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES. NUMEROUS CLIPS WERE UTILIZED TO CONTROL BLEEDING THAT OCCURRED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22594907 ↗
• MalfunctionJun 25, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, FIRING COULD NOT BE DONE AT ALL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331663 ↗
• MalfunctionApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE EGIAUSTND ENDOGIA ULTRA UNIV STD STAP, THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES DUE TO BLEEDING OR OOZING OBSERVED ALONG THE STAPLE LINES AFTER FIRING THREE VASCULAR RELOADS TO TRANSECT BLOOD VESSELS. THE SURGEON NOTED VARYING DEGREES OF BLEEDING ALONG THE STAPLE LINES, WHICH CEASED AFTER SWITCHING TO A DIFFERENT LOT OF THE STAPLER.

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

  MAUDE report 21760229 ↗
• MalfunctionMar 2, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER IN A LOBECTOMY, DURING VASCULAR RESECTION, THE STAPLE HAD COME OUT FROM THE BEGINNING AND FIRING COULD NOT BE PERFORMED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501130 ↗
• MalfunctionOct 24, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC LOBECTOMY, WHEN APPLIED ON THE BLOOD VESSEL, THE FIRING COULD NOT BE PERFORMED COMPLETELY. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523007 ↗
• MalfunctionSep 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE MOMENT OF FIRING, THE HANDLE AND RELOAD DID NOT WORK. A NEW HANDLE AND RELOAD FROM A DIFFERENT MANUFACTURER WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130145 ↗
• DeathAug 15, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE TO REMOVE A RIGHT UPPER LOBE DUE TO LUNG CANCER, THE PATIENT'S SATURATION LEVELS AND PRESSURE KEPT DROPPING. PATIENT WAS CONVERTED FROM A ROBOTIC SURGERY TO AN OPEN SURGERY TO GAIN MORE CONTROL FOR ANESTHESIA TO INFLATE THE LUNGS. THE SURGEON FIRED A SMALL-DIAMETER RELOAD (PARTIALLY FIRED) ON THE PULMONARY ARTERY AND HAD SOME OOZING (THERE WAS BLOOD LOSS). TO CONTROL THE BLEEDING, A BLOOD TRANSFUSION AND A CELL SAVER WERE MADE. SUTURING TO REPAIR THE TEAR IN THE VESSEL WOULD HAVE BEEN THE RESOLUTION, BUT THE PATIENT COULD NOT GET STABLE. THE PATIENT THEN BEGAN TO CRASH FURTHER. A CARDIAC SURGEON WAS CALLED IN, AND RESUSCITATION EFFORTS COMMENCED. THE PATIENT DIED.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Tissue Breakdown

  MAUDE report 19992827 ↗
• 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 19807585 ↗
• MalfunctionJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPICALLY ASSISTED RIGHT UPPER LOBECTOMY, DURING FIRING AT THE INTERLOBAR PULMONARY ARTERY, THE CARTRIDGE SECTION SHAKES SLIGHTLY TO THE LEFT AND RIGHT ABOUT FIVE TIMES. AFTER FIRING, THERE WAS A STAPLE LINE BLEEDING FROM THE BLOOD VESSEL STUMP. THE SURGEON APPLIED PRESSURE HEMOSTASIS FOR ARTERIAL BLEEDING AND USE A HEMOSTATIC AGENT TO STOP THE BLEEDING. BLEEDING WAS OBSERVED AGAIN IN THE SAME SITE WHEN THE LYMPH NODE WAS RESECTED, SO A HEMOSTASIS TREATMENT WAS PERFORMED AGAIN. THERE WAS A TISSUE DAMAGED AND SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

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

  MAUDE report 19529141 ↗
• MalfunctionMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC LOBECTOMY, WHEN THE DEVICE WAS USED ON ONE OF THE PULMONARY VESSELS, THE STAPLE LINE WAS OOZIER THAN THE SURGEON NORMALLY EXPECTED. THE SURGEON USED A METAL CLIP UNDER THE STAPLE LINE TO RESOLVE THE BLEEDING.

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

  MAUDE report 19354004 ↗
• MalfunctionMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOBECTOMY, DURING CLAMPING OF THE ARTERY, ONE SIDE WAS STAPLED AND LOOKED GREAT, BUT THE OTHER SIDE OPENED EVEN THOUGH IT HAD STAPLE. THE PART THAT REMAINED WITH THE PATIENT WAS STAPLED AND THE PART THAT WAS GOING TO COME OUT OPENED. THERE WAS A BLEEDING OF MORE THAN 500CC. THE ISSUE DID NOT REQUIRE ANY INTERVENTION ASIDE FROM COMPRESSION WITH GAUZE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19252305 ↗
• MalfunctionFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, DURING A LAPAROSCOPIC RIGHT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) UPPER LOBECTOMY, FOR RIGHT UPPER LOBE LUNG CANCER STATUS POST CHEMOTHERAPY AND IMMUNOTHERAPY, A SMALL ACCESSORY VESSEL WAS ENCOUNTERED AND DIVIDED WITH THE GRAY LOAD. THERE WAS A SMALL AMOUNT OF PULMONARY ARTERY BLEEDING IN THE DISTALLY DIVIDED VESSEL AND RE-DIVIDED WITH GOOD HEMOSTASIS. CONCOMITANT OR ADDITIONAL TREATMENT GIVEN DUE TO THIS ADVERSE EVENT. THERE WAS APPLICATION OF A 2ND FIRING OF THE RELOAD; FLO-SEAL AND SURGI-CELL APPLICATION. IT WAS NOTED THAT PATIENT SPO2 WAS 94 %. PATIENT RECOVERED. IT WAS ALSO NOTED THAT THERE WERE 3 RELOADS, BUT ISSUE WAS POSSIBLE RELATED WITH FIRST RELOAD AND CAUSAL RELATIONSHIP WITH STUDY PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18727531 ↗
• MalfunctionFeb 15, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) SEGMENTECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE. IT WAS NOTED THAT THE RELOAD PRE-FIRED. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712258 ↗
• MalfunctionDec 19, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PULMONARY SEGMENTECTOMY, FIRING COULD NOT BE PERFORMED DURING PULMONARY VEIN RESECTION. THE SURGEON COULD PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. A NEW HANDLE AND CARTRIDGE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359744 ↗
• MalfunctionDec 7, 2023Failure 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 AT THORACOSCOPIC UPPER LEFT UPPER LOBECTOMY PA (PULMONARY ARTERY) (A3) RESECTION, AT THE TIME OF VESSEL RESECTION, THERE WAS NO POOR FORMATION OF STAPLES, BUT A BLEEDING THAT OCCURRED IN A LOCATION WHERE THE STAPLE WAS NOT FULLY APPLIED TO THE BLOOD VESSEL. COMPRESSION, SOFT COAGULATION, AND CLIPPING WERE PERFORMED TO STOP THE BLEEDING. THIS LED TO TISSUE DAMAGE. IT IS REPORTED AS BLEEDING DUE TO SMALL DIAMETER RELOAD.

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

  MAUDE report 18288662 ↗
• MalfunctionNov 30, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPY LOBECTOMY PROCEDURE, AFTER LOADING THE RELOAD FOR BLOOD VESSEL RESECTION, THE DISPLAY SHOWED AN EXCESSIVE FORCE ZONE MESSAGE BEFORE THE USER CAN CHECK THE OPENING AND CLOSING FUNCTION OF THE JAWS. THE USER THEN UNLOADED AND RELOADED THE RELOAD SEVERAL TIMES, BUT THE ISSUE REMAINED THE SAME. ANOTHER 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 18243415 ↗

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-0485-2026 · Sep 25, 2025 · Open, Classified
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
• 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-1457-2024 · Feb 14, 2024 · Open, Classified
  Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• Z-1458-2024 · Feb 14, 2024 · Open, Classified
  Covidien 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-1383-2021 · Mar 4, 2021 · Terminated
  Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT