Echelon Endopath GST60WRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Echelon Endoscopic Linear Cutter Reloads, White, 60mm · Class 2 · Implant
All models of ECHELON ENDOPATH (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Endopath Echelon reload is a staple cartridge used in minimally invasive surgery to cut and seal tissue. Many of its 286 reports describe staples that do not form properly or the device failing to fire, and surgeons often switched to a new cartridge. The reports include 27 injuries and 2 deaths. 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
- 294
- Deaths reported
- 2
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 10705036014683), received between Dec 7, 2017 and Sep 28, 2026 — classified as 2 deaths, 27 injuries, 265 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (161 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple161
- No Apparent Adverse Event48
- Failure to Fire47
- Adverse Event Without Identified Device or Use Problem23
- Difficult to Open or Close9
- Delivered as Unsterile Product8
- Separation Problem7
- Device Markings/Labelling Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions230
- No Consequences Or Impact To Patient39
- Hemorrhage/Blood Loss/Bleeding34
- Blood Loss8
- No Code Available6
- Failure to Anastomose3
- Fistula3
- Peritonitis3
Recent adverse event reports
The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916392 ↗MalfunctionSep 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916336 ↗MalfunctionSep 21, 2026Failure to Cut
It was reported that during a Lap Gastrectomy, it was observed that the device did not fire farther after fired a little. Changed to a new one to complete the surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841288 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during an unknown surgery, it was observed that the staples were malformed after firing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841191 ↗MalfunctionSep 21, 2026Failure to Form Staple; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50840011 ↗MalfunctionSep 21, 2026Failure to Form Staple; No Apparent Adverse Event
It was reported that during an unknown procedure, it was observed that there was oozing after the staple line and cut line were both completed. Suture was used to oversew. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50839914 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834836 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834834 ↗MalfunctionSep 18, 2026Failure to Form Staple; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50825157 ↗MalfunctionAug 30, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514072 ↗MalfunctionAug 19, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327283 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254449 ↗MalfunctionJun 24, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610777 ↗MalfunctionJun 17, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT AFTER LOADING THE GIA CARTRIDGE AND FIRING, ONLY THE OPERATING SOUND WAS HEARD BUT STAPLING DID NOT OCCUR. WHEN THE CARTRIDGE WAS REPLACED, IT WORKED NORMALLY. THERE WAS NO SURGICAL DELAY AS IT WAS IMMEDIATELY REPLACED WITH A NEW CARTRIDGE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534699 ↗MalfunctionJun 8, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428750 ↗MalfunctionMay 29, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334698 ↗MalfunctionMay 29, 2026Separation Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE; IT WAS OBSERVED THAT THE CARTRIDGE WAS DAMAGED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332178 ↗MalfunctionMay 14, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174009 ↗MalfunctionMay 12, 2026Separation Problem
IT WAS REPORTED THAT DURING A LOWER BOWEL RESECTION, WHEN THE TECH UNLOADED THE STAPLER RELOAD, THE METAL PART ON THE BACK OF THE RELOAD CAME OFF AND STAYED WITHIN THE JAWS OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153078 ↗MalfunctionMay 5, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SOME STAPLES WERE MALFORMED; AND OOZING OCCURRED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 25086174 ↗MalfunctionMay 5, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SOME STAPLES WERE MALFORMED AFTER FIRING; AND OOZING OCCURRED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086001 ↗MalfunctionMay 5, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT A FEW STAPLES WERE FORMED WITH IRREGULAR SHAPES AFTER FIRING; AND ANASTOMOTIC SITE WAS OOZING. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. THEY USED AN ELECTRIC KNIFE TO TREAT COAGULATION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 25083974 ↗MalfunctionMay 4, 2026Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071623 ↗MalfunctionMay 4, 2026Separation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, IT WAS OBSERVED THAT THE METAL COMPONENT OF A RELOAD APPEARED TO DISPATCH AFTER FIRING. THEY WAITED APPROXIMATELY 15 SECONDS, DURING WHICH NO BLEEDING WAS OBSERVED. AS IT WAS UNCLEAR WHETHER THE STAPLES WERE PROPERLY FORMED, THEREFORE THEY ELECTED TO SUTURE THE STAPLE LINE. ALL OTHER RELOADS FUNCTIONED AS EXPECTED WHEN USED WITH THE SAME STAPLER. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069666 ↗MalfunctionApr 24, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987047 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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