Endo GIA 030451Recalls & reported problems
Covidien LP · Universal Articulating Loading Unit · Class 2 · Implant
Quick summary
This Covidien Endo GIA universal articulating loading unit, a stapler cartridge used in surgery, has 109 adverse event reports, with no deaths and 18 injuries. Many reports describe the stapler failing to fire or staples that did not form properly, often requiring a new reload to finish the procedure. 1 recall is closed, started in April 2018, because a part that drives the staples may be missing, which can lead to incomplete staple lines and bleeding.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 109
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10884523002829), received between Mar 15, 2017 and Oct 20, 2025 — classified as 18 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (47 reports).
1 FDA recall record name this device's identifier.
72 other recalls cover devices cleared under the same FDA submission (K111825); 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.
Reports received per month
Recalls naming this device
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1815-2018 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Failure to Fire47
- Failure to Form Staple28
- Adverse Event Without Identified Device or Use Problem15
- Difficult to Open or Close10
- Misfire9
- Detachment of Device or Device Component6
- Break5
- Entrapment of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient26
- No Known Impact Or Consequence To Patient25
- No Code Available10
- Insufficient Information9
- Blood Loss7
- Hemorrhage/Blood Loss/Bleeding7
- Tissue Breakdown6
Recent adverse event reports
The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LUNG SEGMENTECTOMY, SPECIFICALLY AT THE STEP OF DETACHING THE VESSEL, THE TWO HANDLE AND A RELOAD WERE NOT ABLE TO FIRE, AND THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. THE PROBLEM WAS RESOLVED BY REPLACING THE HANDLE AND RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334922 ↗MalfunctionMar 24, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE RELOAD, THE DEVICE WAS NOT ABLE TO FIRE, AND THE SURGEON WAS UNABLE TO SQUEEZE THE MANUAL HANDLE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. THE PRODUCT WAS EXPLANTED AND REPLACED BY ANOTHER DEVICE TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21679832 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY ON CALL FOR A LAPAROSCOPIC APPENDECTOMY. THREE STAPLE MAGAZINES WERE USED DURING THE OPERATION, AT THE MOMENT IT WAS NOT POSSIBLE TO REPORT WHICH MAGAZINE CRASHED INTO THE MANUAL HANDLE. ACCORDING TO THE OPERATING ROOM NURSE AND THE SURGEON, THEY FOUND NOTHING ABNORMAL AT THE STAPLE LINE OR ANY FOREIGN MATERIAL IN THE ABDOMEN. 9 DAYS AFTER THE LAPAROSCOPIC APPENDECTOMY SURGERY, REOPERATION WAS DONE WHERE THE STAPLE LINE HAS RUPTURED. THERE WAS STAPLE LINE LEAK. CORRECTION OF STAPLING LINE BY SUTURES WAS MADE, DRAINAGE OF ABSCESS AND SEARCH FOR FOREIGN BODY WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT FECALITIS WAS FOUND, WHICH INVOLVES THE DISTAL ILEUM AND THE CECAL POLE. NO FOREIGN MATERIAL CAN BE FOUND IN THE ABDOMEN.
Patient problems: Abscess; Rupture; Tissue Breakdown
MAUDE report 21393765 ↗MalfunctionJan 3, 2025Failure to Fire; Fail-Safe Problem; Failure to Fire; Fail-Safe Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE PROXIMAL STAPLES POKED OUT OF THE CARTRIDGE UNFORMED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069091 ↗MalfunctionAug 26, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, WHEN PERFORMING A VASCULAR DISSECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, THE DEVICE WAS NOT ABLE FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20069263 ↗MalfunctionMay 9, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LIVER RESECTION, WHEN DETACHING THE LEFT HEPATIC VEIN, SOME STAPLES WERE POORLY FORMED. ADDITIONAL SUTURING FOR THE INCISION WAS PERFORMED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.
Patient problems: Tissue Breakdown
MAUDE report 19275738 ↗MalfunctionMay 6, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY PROCEDURE, WHILE PREPARING TO DISSOCIATE THE LOBULAR VEIN, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249338 ↗MalfunctionApr 23, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, DURING RESECTION OF THE RECTUM, THE STAPLE LINE WAS INCOM PLETE PROXIMALLY AND THE STAPLES WERE POORLY FORMED. THE STAPLE LINE WAS FIXED BY SUTURE AND A NEW RELOAD WAS USED TO COMPLETE THE CASE.
Patient problems: Tissue Breakdown
MAUDE report 19166323 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A SUB-COSTAL HEPATECTOMY, THERE WAS NO ISSUE WHEN 30 AND 45 MILLIMETER WHITE RELOADS WERE USED. HOWEVER, FIVE HOURS LATER, THE PATIENT WAS TAKEN BACK TO THE EMERGENCY ROOM DUE TO BLEEDING. THE STAPLE LINE WAS OPEN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18837790 ↗MalfunctionJan 26, 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 ROBOTIC LAPAROSCOPIC DA VINCI NEPHRECTOMY, THE STAPLER WAS USED FOR RENAL VEIN, THE STAPLER FIRED, BUT ONLY ONE SIDE OF STAPLES FORMED, WITH ANOTHER SIDE OF STAPLES WERE MISSING. WHEN THE BLOOD VESSELS ON ONE SIDE WERE NOT COMPLETELY CLOSED, THIS RESULTED IN MINIMAL VESSEL BLEEDING OF ABOUT 10CC. CLIP WAS USED TO CLOSE RENAL VEIN OR BLOOD VESSELS AND RESOLVE THE ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 18588560 ↗MalfunctionJan 10, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A VATS (VIDEO-ASSISTED THORACIC SURGERY) LOBECTOMY PROCEDURE, THE USER WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18489533 ↗MalfunctionJan 3, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, IN AN OPEN LOBECTOMY, WHEN STAPLING THE LUNG VESSEL, THE DEVICE FIRED, BUT THE STAPLES WERE POORLY FORMED AND INCOMPLETE. THE STAPLES IN THE MIDDLE OF THE VESSEL STAPLE LINE WERE PARTIALLY OPEN. BOTH SIDES OF THE VESSEL, THE RESECTION SIDE AND THE PATIENT SIDE, WERE OPEN. SOME STAPLES AT THE BEGINNING AND AT THE END OF THE STAPLE LINE WERE FORMED. TO RESOLVE THE ISSUE, BOTH SIDES OF THE OPEN LOBE ARTERIES (RESECTION AND PATIENT SIDE) WERE CLAMPED, COMPRESSED, AND OVER SEWED. THERE WAS BLOOD LOSS OF APPROXIMATELY 1.700 CC. NO BLOOD TRANSFUSION WAS NECESSARY. THE PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.
Patient problems: Great Vessel Perforation; Tissue Breakdown
MAUDE report 18440261 ↗MalfunctionOct 3, 2023Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEPATIC SURGERY, WHILE CUTTING THE HEPATIC VEIN, THE STAPLER DID NOT FIRE. THE SURGEON COULD PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE JAWS OF THE DEVICE WERE LOCKED ON TISSUE AND REMOVED WHEN FORCE OPENED USING A RIGHT-ANGLE RETRACTOR. THE RELOAD WAS REPLACED AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862715 ↗MalfunctionSep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A LAPAROSCOPIC PNEUMONECTOMY WHERE THE DEVICE WAS USED TO ANASTOMOSE VESSEL WITH NO ISSUES, AFTER THE SURGERY WITH THE PATIENT STILL IN THE OR, THE SURGEONS NOTICED BLOOD IN THE DRAIN. THE PATIENT¿S BLOOD PRESSURE DRASTICALLY DECREASED TO 30/10 MMHG. THERE WAS CESSATION OF CIRCULATION IN THE MECHANISM OF PULSELESS ELECTRICAL ACTIVITY. THE ANESTHESIOLOGIST BEGAN RESUSCITATION, IN THE MEANTIME THE SURGEON OPENED THE CHEST OF THE PATIENT AND STOPPED THE BLEEDING. THE SURGEON NOTICED AFTER OPENING THE CHEST, THAT THE TWO STAPLE LINES WERE OPENED/BROKEN, AND THE BLEEDING WAS IN THAT PLACE. THE PATIENT HAD AN ISCHEMIC STROKE. THERE WAS BLOOD LOSS OF MORE THAN 500CC WHICH REQUIRED THE PATIENT A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 120 MINUTES DUE TO THE PRODUCT PROBLEM. THE PATIENT IS STILL IN THE HOSPITAL. CONSEQUENTLY, AFTER THE STROKE, THE PATIENT HAS RIGHT HEMIPARESIS WITH APHASIA.
Patient problems: Asystole; Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Laceration(s); Low Blood Pressure/ Hypotension; Paresis; Speech Disorder
MAUDE report 17738479 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A LAPAROSCOPIC PNEUMONECTOMY WHERE THE DEVICE WAS USED TO ANASTOMOSE VESSEL WITH NO I SSUES, AFTER THE SURGERY WITH THE PATIENT STILL IN THE OR, THE SURGEONS NOTICED BLOOD IN THE DRAIN. THE PATIENT¿S BLOOD PRESSURE DRASTICALLY DECREASED TO 30/10 MMHG. THERE WAS CESSATION OF CIRCULATION IN THE MECHANISM OF PULSELESS ELECTRICAL ACTIVITY. THE ANESTHESIOLOGIST BEGAN RESUSCITATION, IN THE MEANTIME THE SURGEON OPENED THE CHEST OF THE PATIENT AND STOPPED THE BLEEDING. THE SURGEON NOTICED AFTER OPENING THE CHEST, THAT THE TWO STAPLE LINES WERE OPENED/BROKEN, AND THE BLEEDING WAS IN THAT PLACE. THE PATIENT HAD AN ISCHEMIC STROKE. THERE WAS BLOOD LOSS OF MORE THAN 500CC WHICH REQUIRED THE PATIENT A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 120 MINUTES DUE TO THE PRODUCT PROBLEM. THE PATIENT IS STILL IN THE HOSPITAL. CONSEQUENTLY, AFTER THE STROKE, THE PATIENT HAS RIGHT HEMIPARESIS WITH APHASIA.
Patient problems: Asystole; Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Laceration(s); Low Blood Pressure/ Hypotension; Paresis; Speech Disorder
MAUDE report 17736802 ↗MalfunctionAug 18, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT ASSISTED RADICAL NEPHRECTOMY, THE STAPLER DID NOT FIRE. THE HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17577083 ↗MalfunctionJul 19, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, IN THE VESSEL, THE STAPLE LINE OF THE FIRST DEVICE WAS PROXIMALLY INCOMPLETE. A NEW HANDLE AND RELOAD WERE USED, BUT THE SURGEON COULD NOT SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.
Patient problems: Unspecified Tissue Injury
MAUDE report 17356108 ↗MalfunctionJul 19, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, IN THE VESSEL, THE STAPLE LINE OF THE FIRST DEVICE WAS PROXIMALLY INCOMPLETE. A NEW HANDLE AND RELOAD WERE USED, BUT THE SURGEON COULD NOT SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.
Patient problems: Insufficient Information
MAUDE report 17355894 ↗MalfunctionJul 17, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE COULD NOT BE FIRED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 17335592 ↗MalfunctionJul 13, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOBECTOMY, DURING THE LOBECTOMY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE STAPLER WAS ABLE TO FIRE BUT THERE WAS POOR STAPLE FORMATION. THE STAPLES BURST OUT. THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. THE SAME ISSUE OCCURRED IN ANOTHER RELOAD. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE.
Patient problems: Tissue Breakdown
MAUDE report 17321313 ↗MalfunctionJun 21, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY LOBECTOMY, WHILE DETACHING LUNG PARENCHYMA, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE HANDLE WAS NOT SQUEEZED AND DEVICE DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172634 ↗MalfunctionJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACIC SURGERY, AFTER FIRING THE DEVICE, THERE WAS A LITTLE BLEEDING. A MONOPOLAR ENERGY DEVICE WAS USED TO STOP THE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17049678 ↗MalfunctionMay 5, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16880552 ↗MalfunctionApr 11, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SEGMENTECTOMY, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED. ALL THREE RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16715858 ↗MalfunctionApr 11, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SEGMENTECTOMY, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED. ALL THREE RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16715829 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111825. One submission often covers many models, so check the product and lot details in each record.
- Z-0748-2021 · Nov 23, 2020 · CompletedCovidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
- Z-0747-2021 · Nov 23, 2020 · CompletedCovidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tr
- Z-0005-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
- Z-0009-2021 · Aug 12, 2020 · Open, ClassifiedCovidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
- Z-0004-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
- Z-0002-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
- Z-0008-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
- Z-0003-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
- Z-0007-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
- Z-0006-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
- Z-0001-2021 · Aug 12, 2020 · Open, ClassifiedEndo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
- Z-1264-2020 · Jan 17, 2020 · TerminatedCovidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
…and 57 more.
Other STAPLE, IMPLANTABLE devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.