Endo GIA EGIA45AMT (UDI 10884521820555)Recalls & reported problems
Covidien LP · Articulation Reload with Tri-Staple Technology · 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 reload is a surgical stapling cartridge used to cut and seal tissue inside the body. The 53 reports mostly describe the stapler failing to fire, jamming or locking onto tissue, not forming a complete staple line, or breaking, sometimes forcing surgeons to convert to open surgery or hand-suture the area. Four reports describe patient injuries and there are no deaths. Reports mentioning this device identifier fell from 15 in the prior 12 months to 1 in the last 12 months, and no recalls name it.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10884521820555), received between Dec 23, 2021 and Mar 12, 2026 — classified as 4 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (20 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire20
- Misfire9
- Entrapment of Device8
- Failure to Form Staple8
- Break7
- Difficult to Open or Close6
- Insufficient Device Problem Information5
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information8
- Tissue Breakdown6
- Hemorrhage/Blood Loss/Bleeding5
- Failure to Anastomose4
- Unspecified Tissue Injury3
- Laceration(s)1
- Melena1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Failure to Fire
ACCORDING TO THE REPORTER, IN AN APPENDECTOMY, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THE CLAMP ONLY OPENED AND CLOSED. ANOTHER DEVICE FROM THE SAME CODE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR TWO MINUTES AS A RESULT. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24577275 ↗MalfunctionSep 18, 2025Misfire; Failure to Fire; Misfire; Failure to Fire
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLE RELOAD FOR THE LAPAROSCOPIC CUTTING STAPLER WAS CORRECTLY INSTALLED. HOWEVER, THE STAPLER GOT STUCK DURING FIRING. A REPLACEMENT CUTTING STAPLER OF THE SAME MODEL WAS USED TO DETACH THE LUNG TISSUE, BUT A STAPLER JAM STILL OCCURRED DURING FIRING, RENDERING IT UNUSABLE. THE SURGICAL TIME WAS PROLONGED AS A RESULT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23085522 ↗MalfunctionSep 18, 2025Misfire; Failure to Fire; Misfire; Failure to Fire
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLE RELOAD FOR THE LAPAROSCOPIC CUTTING STAPLER WAS CORRECTLY INSTALLED. HOWEVER, THE STAPLER GOT STUCK DURING FIRING. A REPLACEMENT CUTTING STAPLER OF THE SAME MODEL WAS USED TO DETACH THE LUNG TISSUE, BUT A STAPLER JAM STILL OCCURRED DURING FIRING, RENDERING IT UNUSABLE. THE SURGICAL TIME WAS PROLONGED AS A RESULT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23085334 ↗MalfunctionJul 28, 2025Entrapment of Device; Retraction Problem; Calibration Problem; Entrapment of Device; Retraction Problem; Calibration Problem
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, WHILE ON CREATION OF THE GASTROJEJUNAL ANASTOMOSIS, AFTER FIRING, THE SURGEON SAW THE POWERED STAPLER TWITCH, THEN RELOAD WOULD NOT RETRACT THE KNIFE BLADE. IT WAS ALSO STATED THAT THE JAWS DID NOT OPEN AND LOCKED ON TISSUE. THE SURGEON WAS INSTRUCTED TO PRESS THE QUICK-RELEASE BUTTON ON TOP OF THE ADAPTER WHILE SIMULTANEOUSLY PULLING THE STAPLING HANDLE OFF THE ADAPTER. UPON CONNECTION TO THE ADAPTER, THE DEVICE DID RECOGNIZE A RELOAD WAS ATTACHED BUT STILL GAVE A RELOAD ERROR MESSAGE ON THE SCREEN. THE ADAPTER COULD NOT BE CALIBRATED. WHEN ATTEMPTING TO ZERO OUT THE CONTROLS, FORCING THE KNIFE TO RETRACT AND OPEN, THE STAPLING RELOAD REMAINED IN THE LOCKED POSITION ON THE TISSUE. SINCE THE REBOOT APPROACH WAS UNSUCCESSFUL, THE SURGEON WAS ASKED TO USE THE MANUAL RETRACTION TOOL AND INSTRUCTED TO REMOVE THE POWER STAPLING HANDLE FROM THE ADAPTER BY PRESSING THE QUICK-RELEASE BUTTON ON THE ADAPTER WHILE PULLING THE HANDLE OFF THE ADAPTER. THE SURGEON WAS ASKED TO ATTEMPT RETRACTION OF THE KNIFE AND OPEN THE JAWS OF THE STAPLING RELOAD BY TURNING THE MANUAL RETRACTION TOOL CLOCKWISE, THE SAME DIRECTION AS T
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22638788 ↗InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, WHILE ON ESOPHAGEAL JEJUNUM ANASTOMOTIC, THE FIRING WAS MISTAKENLY PERFORMED AT THE TIP SIDE OF THE SILICONE DISK USED FOR LIVER RETRACTION. THE SURGERY WAS TRANSITIONED TO LAPAROTOMY IN ORDER TO REMOVE THE PART THAT WAS FIRED IN THE SILICONE DISK.
Patient problems: Laceration(s)
MAUDE report 22609644 ↗MalfunctionJul 24, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A RADICAL SURGERY FOR LUNG CANCER, WHEN DETACHING THE LUNG PARENCHYMA, THE STAPLE LINE WAS INCOMPLETE CENTRALLY AND THE STAPLES WERE NOT FORMED. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED AND SUTURING WAS DONE TO REINFORCE THE STAPLE LINE.
Patient problems: Tissue Breakdown
MAUDE report 22585300 ↗MalfunctionJul 22, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event
ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE USE ON PATIENT, THE DEVICE DID NOT FIRE. ANOTHER HANDLE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22564642 ↗MalfunctionJul 22, 2025Entrapment of Device; Firing Problem; Entrapment of Device; Firing Problem
IT WAS REPORTED THAT DURING A COMBINATION OF CYTOREDUCTIVE SURGERY (CRS) AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) PROCEDURE, THE HANDLE REQUIRED EXCESSIVE FORCE WHILE FIRING AND GETS LOCKED ON TISSUE AFTER FIRING. THE DEVICE WAS REPLACED BY ANOTHER HANDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564257 ↗MalfunctionJul 15, 2025Retraction Problem; Retraction Problem
ACCORDING TO THE REPORTER DURING AN APPENDECTOMY, WHEN ATTEMPTING TO FIRE, THE SHELL AND ADAPTER DETACHED. IT WAS NOTED THAT THE CONNECTION BETWEEN THE SHELL AND ADAPTER WAS NOT LOOSE. AFTERWARDS EVEN AFTER ATTACHING THE ADAPTER, THE FIRING DID NOT RETURN SO IT WAS RELEASED USING THE MANUAL ADAPTER. ANOTHER HANDLE AND ADAPTER WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505529 ↗MalfunctionJul 9, 2025Unintended Movement; Unintended Movement
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC APPENDECTOMY, WHEN THE APPENDIX WAS RESECTED THE CARTRIDGE WAS ARTICULATED BOTH BEFORE AND AFTER THE FIRING. THE HANDLE WAS STRAIGHT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22465462 ↗MalfunctionApr 17, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTUM RESECTION, AN ATTEMPT WAS MADE TO RELEASE THE CARTRIDGE FROM THE ADAPTER, BUT IT COULD NOT BE REMOVED PROPERLY, AND THE CONNECTION PART OF THE CARTRIDGE BROKE. THE JAW OF THE CARTRIDGE HAD BEEN OPENED AT THE TIME OF RELEASE, AND THE SHAFT WAS STRAIGHT. THE ISSUE OCCURRED AFTER THE PROCEDURE WHEN REMOVING THE CARTRIDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21859072 ↗MalfunctionFeb 18, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A DEEP ANTERIOR RECTAL RESECTION PROCEDURE, THE ATTACHMENT MAGAZINE WAS BROKEN DURING PLACEMENT AND BEFORE DEPLOYMENT. IT WAS ALSO NOTED THAT THE BROKEN MAGAZINE WAS STILL IN THE ADAPTER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405640 ↗MalfunctionFeb 6, 2025Break; Misfire; Noise, Audible; Break; Misfire; Noise, Audible
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS DIFFICULT TO FIRE. WHEN THE OPERATOR SQUEEZED ONCE, THE HANDLE SOUNDED LOUDLY. THE HANDLE BROKE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329808 ↗MalfunctionJan 14, 2025Entrapment of Device; Retraction Problem; Firing Problem; Entrapment of Device; Retraction Problem; Firing Problem
ACCORDING TO THE REPORTER, IN A THORACOSCOPIC RIGHT UPPER LOBECTOMY, WHEN IN THE LUNG PARENCHYMA, THE DEVICE WAS STIFF TO SQUEEZE. THERE WAS NO ISSUE WITH THE STAPLE LINE BUT THERE WAS FAILURE TO RETRACT KNIFE BLADE AFTER FIRING. THE JAWS COULD NOT BE REMOVED FROM THE TISSUE. THE RELOAD HAD TISSUE AND A STAPLE REMAINING AT THE ROOT OF THE JAWS. THE RETURN KNOB WAS PULLED BACK FORCEFULLY WITH BOTH HANDS TO REMOVE THE DEVICE FROM THE TISSUE. THE SURGICAL TEAM STRUGGLED TO PULL BACK THE DEVICE FOR 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149455 ↗MalfunctionDec 9, 2024Entrapment of Device; Failure to Fire; Insufficient Device Problem Information; Entrapment of Device; Failure to Fire; Insufficient Device Problem Information
DUPLICATE PE OF (B)(4) ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT LOBECTOMY UNDER TRACHEAL ANESTHESIA DUE TO A MALIGNANT TUMOR IN THE RIGHT LUNG, THE DEVICE DID NOT FIRE. AFTER REPEATED OPERATION, THE DEVICE COULD NOT BE EJECTED TO STOP THE BLEEDING. A NEW HANDLE FROM THE SAME BATCH WAS USED TO STOP THE BLEEDING AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878959 ↗MalfunctionNov 18, 2024Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO RELOADS DID NOT CLOSE TOTALLY. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BY FIVE MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707115 ↗MalfunctionSep 27, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESECTION OF A RECTAL MALIGNANT TUMOR, WHEN APPROACHED THE TISSUE DURING RECTAL RESECTION, THE FIRING COULD NOT BE DONE AND THE HANDLE COULD NOT BE SQUEEZED. 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 20322923 ↗MalfunctionSep 17, 2024Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE ADAPTER AND RELOAD COULD NOT BE REMOVED. WHEN REMOVING THE RELOAD, NOT FROM THE TISSUE, THE JAWS WOULD NOT OPENED. TREATMENT INTERVENTION WAS NOT PERFORMED AND NECESSARY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242730 ↗MalfunctionAug 7, 2024Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A BARIATRIC GASTRIC BYPASS, THE STAPLER WORKED WITHOUT ANY ISSUE WHEN THE SURGEON STAPLED THE INTESTINE AND STOMACH. DURING THE SECOND FIRING, THE CHARGE STARTED TO DEVELOP AND IT GOT STUCK, WHICH CAUSED THE HANDLE TO BREAK. A NEW RELOAD WAS OPENED, BUT IT DID NOT WORK. THE HANDLE WAS REPLACED WITH ANOTHER ONE AND THE STAPLE WORKED NORMALLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19932563 ↗MalfunctionJul 23, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, DURING THORACOSCOPY PULMONARY RESECTION, AT THE TIME OF PULMONARY PARENCHYMA DISSECTION, THE FIRING COULD NOT BE PERFORMED AT ALL, EVEN AFTER THE GREEN BUTTON WAS PRESSED. IT WAS NOTED THAT THERE WERE STAPLES PROTRUDING FROM THE BASE OF THE CARTRIDGE JAW. 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 19812631 ↗MalfunctionJul 7, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, WHILE PERFORMING INTERLOBAR RESECTION, THE BRONCHUS WAS RESECTED USING A THREAD. HOWEVER, THE END OF THE THREAD WAS UNINTENTIONALLY LEFT BEHIND. WITHOUT NOTICING THAT THE REMAINING END OF THE THREAD HAD BECOME TRAPPED BETWEEN THE LOBES, IT WAS SEPARATED USING A 45AMT RELOAD. THE THREAD BECAME ENTANGLED ON THE SURFACE OF THE RELOAD AND COULD NOT BE REMOVED. TO RESOLVE THE ISSUE, THE THREAD WAS CUT WITH SCISSORS, AND BOTH THE TISSUE AND THE RELOAD WERE THEN REMOVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686847 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, FIVE DAYS AFTER A LAPAROSCOPIC VIDEO ROUX EN Y GASTROPLASTY, THE PATIENT HAD MELENA (BLACK TARRY STOOLS) WITH GRADUAL INCREASE. THE PATIENT HAD BLEEDING WHICH REQUIRED REOPERATION FOUR DAYS LATER. THE SUTURE REMAINS ANCHORED TO THE STAPLE PAD.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Melena
MAUDE report 19288939 ↗InjuryApr 25, 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, THE EVENING POST-OPERATIVE OF A LAPAROSCOPIC ROUX-N-Y GASTRIC BYPASS WHERE THE DEVICE WAS USED DURING THE GASTROJEJUNOSTOMY (GJ) ON THE SECOND FIRING OF THE POUCH, THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) DUE TO BLEEDING FROM CORNER OF THE GASTROJEJUNOSTOMY STAPLE LINE. IT WAS STATED THAT THERE WAS POOR STAPLE FORMATION. THE STAPLES DID NOT FORM COMPLETELY. THE SURGEON ENDED UP DOING AN ICU ENDOSCOPY CLIP ON THE CORNER TO STOP THE BLEEDING. THE PATIENT¿S HOSPITAL STAY WAS EXTENDED. THE PATIENT STAYED IN THE ICU FOR 7 DAYS. IT WAS STATED THAT DURING THE INITIAL PROCEDURE, THE STAPLE LINE WAS EXAMINED AND THERE WAS NO KNOWN BLEEDING DURING PROCEDURE.
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 19185027 ↗MalfunctionApr 18, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BOWEL RESECTION, AFTER CLAMPING THE DEVICE INTO THE BOWEL, THE GREEN BUTTON WAS PRESSED. HOWEVER, THE FIRING MECHANISM DID NOT ENGAGE; THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. A NEW HANDLE AND RELOAD WERE OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19140486 ↗MalfunctionApr 2, 2024Unintended Movement; Unintended Movement
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, DURING THE FOURTH FIRING OF FUNCTIONAL END-TO-END ANASTOMOSIS, AFTER THE LEFT ARTICULATION OPERATION WAS PERFORMED WHILE OUTSIDE THE PATIENT CAVITY, THE RIGHT ARTICULATION STARTED BY ITSELF WITHOUT BUTTON OPERATION, AND IT OPERATED UP TO ABOUT 30 DEGREES OF RIGHT ARTICULATION. IT WAS DISCOVERED THAT WHEN THE RIGHT ARTICULATION WAS STARTED, THE FINGER HAS NOT BEEN TOUCHED WITH THE TRIGGER AT ALL. A NEW HANDLE AND SHELL WERE USED WITH THE SAME ADAPTER AND CARTRIDGE AND FIRING WAS PERFORMED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020745 ↗
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-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-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-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-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-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-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-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-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-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-1264-2020 · Jan 17, 2020 · TerminatedCovidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
…and 58 more.
Other Staple, implantable devices
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- 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 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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