Endo GIA 030412Recalls & reported problems
Covidien LP · Universal Loading Unit · Class 2 · Implant
All models of Endo GIA (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Endo GIA universal loading unit is a surgical stapler used to cut and seal tissue during laparoscopic and open procedures. The 67 reports mostly describe the stapler failing to fire, staples that would not form properly or burst after firing, and a handle that would not open or close, sometimes forcing surgeons to switch to another device or hand-suturing the site. Reports mention 2 deaths and 7 injuries. No recalls name this device.
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
- 67
- Deaths reported
- 2
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884523002911), received between Aug 29, 2017 and Jun 5, 2023 — classified as 2 deaths, 7 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (26 reports).
73 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Fire26
- Failure to Form Staple19
- Difficult to Open or Close13
- Misfire7
- Detachment of Device or Device Component4
- Adverse Event Without Identified Device or Use Problem3
- Human-Device Interface Problem3
- Break2
Patient problems
- No Known Impact Or Consequence To Patient20
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient17
- No Code Available5
- Unspecified Tissue Injury3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- Blood Loss1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMI-HEPATECTOMY, DURING DETACHING OF THE HEPATIC VEIN, AFTER PRESSING THE GREEN BUTTON, THE HANDLE WAS STUCK AND THE DEVICE COULD NOT BE FIRED. THE SURGEON CONTINUED TO PRESS THE FIRING GRIP, BUT THE HANDLE DID NOT RESPOND. A SECOND RELOAD WAS USED WITH THE SAME HANDLE, HOWEVER THE STAPLER STILL FAILED TO FIRE. IT WAS NECESSARY TO REPLACE BOTH HANDLE AND RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17059718 ↗MalfunctionApr 24, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, IN ESOPHAGEAL JEJUNOSTOMY, ON TWO RELOADS, THERE WERE POOR STAPLE FORMATION. TO RESOLVE THE ISSUE, A NEW SIXTY MILLIMETER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16796699 ↗MalfunctionApr 24, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, IN ESOPHAGEAL JEJUNOSTOMY, ON TWO RELOADS, THERE WERE POOR STAPLE FORMATION. TO RESOLVE THE ISSUE, A NEW SIXTY MILLIMETER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16796689 ↗MalfunctionApr 7, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEPATECTOMY PROCEDURE, IN DISSOCIATING THE RIGHT HEPATIC VEIN, THE SURGEON COULD PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD OF THE SAME TYPE WERE USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704593 ↗MalfunctionJan 23, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC BYPASS RESECTION, THE NURSE OPENED THE ASEPTIC PACKAGE OF THE HANDLE AND TESTED THE RELOAD. AFTER THE INSTALLATION WAS SUCCESSFUL, THE DOCTOR NORMALLY INSERTED THE STAPLES INTO THE PATIENT'S ABDOMINAL CAVITY THROUGH THE TROCAR TO PREPARE FOR GASTRECTOMY. THE DOCTOR SUCCESSFULLY CLAMPED THE GASTRIC TISSUE, PRESSED THE GREEN SAFETY BUTTON, AND WAS READY TO FIRE THE BLUE RELOAD. THE BLUE RELOAD COULD BE FIRED NORMALLY, BUT AFTER THE FIRING, THE STAPLE FAILED TO CLOSE AND FORM. DOCTOR AND NURSE PREDICTED THAT IT COULD NOT BE USED NORMALLY, SO IT WAS REPLACED WITH THE SAME MODEL, AND THE GASTRIC TISSUE WAS SUCCESSFULLY ANASTOMOSED. WHEN THE DOCTOR PERFORMED INTESTINAL ANASTOMOSIS, PRESSED THE GREEN SAFETY BUTTON TO PREPARE TO FIRE THE WHITE RELOAD, WHICH COULD BE FIRED NORMALLY, BUT AFTER FIRING, THE STAPLE COULD NOT BE CLOSED AND COULD NOT BE FORMED SUCCESSFULLY. THE WHITE RELOAD WAS REPLACED WITH THE SAME MODEL AND THE GASTRIC TISSUE WAS SUCCESSFULLY ANASTOMOSED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16223289 ↗MalfunctionJan 10, 2023Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC PSEUDOCYST RESECTION SURGERY, IT WAS FOUND THAT THE DEVICE COULD NOT BE COMPLETELY CLOSED. THE DOCTOR IMMEDIATELY USED MANUAL SUTURE TO CLOSE THE SMALL INTESTINE, AND THE SURGERY WAS COMPLETED. THE SURGICAL TIME WAS EXTENDED FOR SOME TIME, AND THE EXACT TIME WAS UNKNOWN. ANASTOMOSIS BY HAND SUTURING WAS DONE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16131710 ↗MalfunctionNov 22, 2022Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY FOR GASTRIC CANCER, WHEN SEVERING THE DUODENUM, THE DEVICE FIRED BUT THE STAPLES BURST. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15847720 ↗DeathNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE EFFICACY AND SAFETY OF PARENCHYMAL TRANSECTION BY THE VESSEL SEALING DEVICE COMPARED WITH THE STAPLER TECHNIQUE IN PATIENTS WHO UNDERWENT OPEN ELECTIVE HEPATIC RESECTION BETWEEN NOVEMBER 2011 AND JULY 2014. THERE WERE A TOTAL OF 138 PATIENTS: THERE ARE 69 PATIENTS IN THE STAPLER HEPATECTOMY GROUP. IN THE STAPLER GROUP, UNIVERSAL STAPLE WITH 60MILLIMETER (MM) RELOAD WITH 2.5MM STAPLES WERE USED FOR PARENCHYMAL DIVISION. COMPLICATIONS INCLUDED: 6 DEATHS. CAUSE OF DEATH WAS NOT REPORTED. ARTICLE: RANDOMIZED CLINICAL TRIAL OF STAPLER HEPATECTOMY VERSUS LIGASURE¿ TRANSECTION IN ELECTIVE HEPATIC RESECTION AUTHOR: J. FRITZMANN YEAR:2018 PUBLICATION: JOHN WILEY <(>&<)> SONS LTD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15833640 ↗InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE EFFICACY AND SAFETY OF PARENCHYMAL TRANSECTION BY THE VESSEL SEALING DEVICE COMPARED WITH THE STAPLER TECHNIQUE IN PATIENTS WHO UNDERWENT OPEN ELECTIVE HEPATIC RESECTION BETWEEN NOVEMBER 2011 AND JULY 2014. THERE WERE A TOTAL OF 138 PATIENTS: THERE ARE 69 PATIENTS IN THE STAPLER HEPATECTOMY GROUP. IN THE STAPLER GROUP, UNIVERSAL STAPLE WITH 60MILLIMETER (MM) RELOAD WITH 2.5MM STAPLES WERE USED FOR PARENCHYMAL DIVISION. COMPLICATIONS INCLUDED: INTRAOPERATIVE BLEEDING AVERAGING TO 961ML, 24 BILE LEAKS, 3 HEMORRHAGE AFTER HEPATECTOMY, 25 ABDOMINAL FLUID COLLECTION AND 9 SEPSIS. BLOOD TRANSFUSIONS, REOPERATIONS, RADIOLOGIC INTERVENTION AND EXTENDED HOSPITAL STAY WERE REPORTED. ARTICLE: RANDOMIZED CLINICAL TRIAL OF STAPLER HEPATECTOMY VERSUS LIGASURE¿ TRANSECTION IN ELECTIVE HEPATIC RESECTION AUTHOR: J. FRITZMANN YEAR:2018 PUBLICATION: JOHN WILEY <(>&<)> SONS LTD
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Sepsis
MAUDE report 15825147 ↗MalfunctionJul 15, 2022Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING LUNG WEDGE ANASTOMOSIS IN A LAPAROSCOPIC THORACOSCOPIC WEDGE RESECTION OF THE LEFT LUNG, THE 2 RELOADS BURSTS AND THE LEGS OF THE RELOADS CANNOT CLOSE THE TISSUE. SURGEON USED ANOTHER RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15033534 ↗MalfunctionJul 15, 2022Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT LUNG THORACOSCOPIC SEGMENTECTOMY, WHILE ON LUNG SEGMENT ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION FOR BOTH RELOADS. THE STAPLES BURST, WHICH DOES NOT CLOSE THE TISSUE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15033281 ↗InjuryJun 29, 2022Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS PROCEDURE, WHILE THE DUODENUM WAS BEING TRANSECTED TO END ROUX-EN-Y, THE RELOAD SHOT BADLY. THE PNEUMATIC PRESSURE TEST WAS FILTERED. FINALLY, THE SURGEON SUTURED THE STAPLE LINE.
Patient problems: Unspecified Tissue Injury
MAUDE report 14859274 ↗MalfunctionDec 28, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, WHILE PERFORMING JEJUNOJEJUNOSTOMY, THE DEVICE DID NOT FIRE AND A SMALL METAL ROD FROM THE RELOAD FELL INTO THE PATIENT'S CAVITY. THE SURGEON RETRIEVED THE COMPONENT BY USING A GRASPER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13097402 ↗MalfunctionDec 20, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC SURGERY, WHILE STAPLING THE JEJUNUM TO CREATE A MINI-GASTRIC BYPASS (MGB), THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZED THE HANDLE. BUT THE RELOAD DID NOT WORKED AT ALL. THE JAWS OF THE DEVICE LOCK ON TISSUE AND WAS REMOVED NORMALLY. THE SURGEON USED A NEW RELOAD TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE HANDLE WORKED FINE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13044506 ↗MalfunctionNov 10, 2021Misfire; Misfire
ACCORDING TO THE REPORTER, WHILE LIVER RESECTION DURING HEPATECTOMY, WHEN FIRING THE FIRST RELOAD, THERE WAS AN INCOMPLETE STAPLE LINE ON THE DISTAL PART. SURGEON REPLACED THE RELOAD AND UPON FIRING, THE DEVICE WAS NOT ABLE TO FIRE THIS TIME. SURGEON REPLACED BOTH HANDLE AND RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12791213 ↗MalfunctionOct 1, 2021Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC NEPHRECTOMY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THE DEVICE COULD NOT CLOSE ON TO THE UTERINE VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12562043 ↗MalfunctionJul 21, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, THE LOADING UNIT DID NOT FIRE DURING A PROCEDURE. ANOTHER RELOAD WAS OPENED AND SAME HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12207251 ↗MalfunctionMay 14, 2021Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL LUNG RESECTION, THE USER FOUND THAT THE FRONT END OF THE RELOAD COULD NOT BE CLOSED COMPLETELY. THE RELOAD WAS CHECKED BEFORE USE AND THE OUTER PACKAGING WAS INTACT AND WAS WITHIN THE VALIDITY PERIOD. AFTER THE OCCURRENCE, THE SURGICAL NURSE IMMEDIATELY REPLACED WITH ANOTHER LOT OF THE RELOAD AND THE SAME HANDLE WAS USED FOR THE OPERATION, AND THE SURGERY PROCEEDED SMOOTHLY. THERE WAS A DELAY IN THE PROCEDURE OF 10 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11825054 ↗MalfunctionApr 21, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SPLENECTOMY, WHILE THE SPLENIC ARTERY WAS BEING DETACHED, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. THE JAWS OF THE DEVICE REMAINED CLOSED ON TISSUE AFTER FIRING. AFTER THE JAW WAS CLOSED, THE FIRING COULD NOT BE PERFORMED, BUT THE CLEANING HANDLE COULD BE RETURNED WITHOUT BEING STUCK ON THE TISSUE. FORTUNATELY, THE SUTURE WAS LIGATED IN ADVANCE BEFORE THE SPLENIC ARTERY WAS DETACHED, SO THE RELOAD WAS REPLACED WITH A NEW ONE AND RE-DETACHED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11698551 ↗MalfunctionFeb 4, 2021Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO DETACH THE STOMACH AND JEJUNUM DURING LAPAROSCOPIC TOTAL GASTRECTOMY, THE DEVICE WAS ABLE TO FIRE, HOWEVER, THERE WAS A POOR STAPLE FORMATION AND INCOMPLETE STAPLE LINE PROXIMALLY. NEW SET OF DEVICE WAS USED TO FIX THE STAPLE LINE AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11278531 ↗InjuryJan 25, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL GASTRECTOMY, THE DEVICE WAS ABLE TO FIRE BUT COULD ONLY PUSH A LITTLE AND UNABLE TO COMPLETE THE CLOSURE, RESULTING TO AN INCOMPLETE STAPLE LINE DISTALLY. IN ADDITION THERE WERE POOR STAPLE FORMATION. TO RESOLVE THE ISSUE THE SURGEON USED SUTURE AND HAND SEW THE TISSUE.
Patient problems: Unspecified Tissue Injury
MAUDE report 11222348 ↗InjuryJan 11, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y, WHILE TRANSECTING THE ILEUM, THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE AT THE DISTAL PART. THE STAPLE LINE WAS FIXED USING ANOTHER RELOAD AND SUTURING.
Patient problems: Unspecified Tissue Injury
MAUDE report 11148014 ↗MalfunctionDec 14, 2020Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO SPLENIC ARTERY DURING THORACOSCOPY WITH PULMONARY BIOPSY, THE JAWS OF THE RELOAD WOULD NOT CLOSE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 11004236 ↗MalfunctionNov 23, 2020Break; Human-Device Interface Problem; Break; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE HANDLE WAS ABLE TO RECOGNIZE THE RELOAD AND STAPLER WAS ABLE TO FIRE, BUT THE RELOAD WOULD NOT UNLOAD. A MANUAL HANDLE WAS THEN USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT A LOADING UNIT WITH THE APPROPRIATE STAPLE SIZE FOR THE TISSUE THICKNESS. OVERLY THICK OR THIN TISSUE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION. ALWAYS INCLUDE THE COMBINED THICKNESS OF THE TISSUE AND OF ANY STAPLE LINE REINFORCEMENT MATERIAL IN USE WHEN CHOOSING THE PROPER STAPLE CARTRIDGE. WHEN POSITIONING THE INSTRUMENT ON THE APPLICATION SITE, ENSURE THAT NO OBSTRUCTIONS, SUCH AS PREVIOUSLY FIRED STAPLES OR CLIPS, ARE INCORPORATED INTO THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10883327 ↗MalfunctionOct 31, 2020Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DISTAL GASTRIC SURGERY, UPON DUODENAL STUMP ANASTOMOSIS, THE RELOAD COULD NOT BE CLOSED. THE SURGEON REPLACED RELOAD BY A NEW PRODUCT OF SAME ID AND LOT NUMBER TO CONTINUE THE SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10767525 ↗
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 tra
- 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-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-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-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-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-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-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-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-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-1264-2020 · Jan 17, 2020 · TerminatedCovidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
…and 58 more.
Other STAPLE, IMPLANTABLE devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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