Echelon Endopath GST60GRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Echelon Endoscopic Linear Cutter Reloads, Green, 60mm · Class 2 · Implant
Quick summary
This Ethicon Echelon 60mm stapler reload has 515 adverse event reports, including 3 deaths and 29 injuries. Many reports describe staples that do not form properly, the reload failing to fire, and marking or labeling problems. Some mention bleeding during surgery. No recalls name this device. Reports rose to 84 in the last 12 months from 46 in the year before.
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
- 521
- Deaths reported
- 3
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 521 adverse event reports that list this exact device (DI 10705036014713), received between Dec 1, 2017 and Sep 21, 2026 — classified as 3 deaths, 29 injuries, 489 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (181 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple181
- Failure to Fire103
- No Apparent Adverse Event101
- Device Markings/Labelling Problem45
- Tear, Rip or Hole in Device Packaging39
- Material Integrity Problem31
- Adverse Event Without Identified Device or Use Problem23
- Unintended Ejection14
Patient problems
- No Clinical Signs, Symptoms or Conditions409
- No Consequences Or Impact To Patient79
- Failure to Anastomose13
- Hemorrhage/Blood Loss/Bleeding13
- No Code Available10
- Blood Loss8
- Fistula5
- Foreign Body In Patient4
Recent adverse event reports
The 25 most recent of 521 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Failure to Fire
It was reported that during an unspecified surgical procedure, it was observed that the device could not be fired. 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 50840269 ↗MalfunctionSep 18, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829169 ↗MalfunctionSep 18, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829167 ↗MalfunctionSep 17, 2026Failure to Fire
It was reported that during an unspecified surgical procedure, it was observed that the device could not be fired properly. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802855 ↗MalfunctionSep 3, 2026Unintended Ejection; Material Integrity Problem
It was reported that during thoracic surgery, specifically a segmental resection of the left lower lobe, while using the Echelon stapler, a staple load slipped and subsequently broke during use, causing the load to become lodged inside the pleural cavity. Consequently, it was necessary to extend the surgery time to extract the retained fragment. Once the load was retrieved, it was found to have significant slippage of its components, as well as structural damage. It should be noted that this is not the first time this has happened with this device.
Patient problems: Foreign Body In Patient
MAUDE report 50585115 ↗MalfunctionSep 3, 2026Unintended Ejection; Material Integrity Problem
It was reported that during thoracic surgery, specifically a segmental resection of the left lower lobe, while using the Echelon stapler, a staple load slipped and subsequently broke during use, causing the load to become lodged inside the pleural cavity. Consequently, it was necessary to extend the surgery time to extract the retained fragment. Once the load was retrieved, it was found to have significant slippage of its components, as well as structural damage. It should be noted that this is not the first time this has happened with this device.
Patient problems: Foreign Body In Patient
MAUDE report 50585085 ↗MalfunctionSep 2, 2026Ejection Problem; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563193 ↗MalfunctionAug 20, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50353373 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255061 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255060 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254970 ↗MalfunctionAug 3, 2026Failure to Form Staple
It was reported that during an unknown procedure, it was observed that the staples were malformed after firing. Changed to another two to continue the procedure but the same problem happened again. Changed to a new one to complete the procedure. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121884 ↗MalfunctionAug 3, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121871 ↗MalfunctionAug 3, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121862 ↗MalfunctionAug 3, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50119936 ↗MalfunctionJul 27, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046416 ↗MalfunctionJul 27, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50019855 ↗MalfunctionJun 24, 2026Failure to Fire
IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY 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 25612523 ↗MalfunctionJun 24, 2026Failure to Fire
IT WAS REPORTED THAT DURING A LOBECTOMY 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 25609567 ↗MalfunctionJun 19, 2026Failure to Fire
IT WAS REPORTED THAT DURING A LOBECTOMY 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 25566033 ↗MalfunctionJun 15, 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 25504479 ↗MalfunctionJun 8, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A GREEN FRAGMENT FELL OUT AFTER THE 1ST FIRING. UPON CONFIRMING, IT WAS FOUND A CHIP OR SOMETHING SCRAPING THE BASE OF THE PART IT HAD SEPARATED. THE CARTRIDGE COLOR WAS GREEN. AFTER THE COMPLAINT OCCURRED, NOTHING IN PARTICULAR WAS DONE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 25433267 ↗MalfunctionJun 5, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414180 ↗MalfunctionJun 3, 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 25379431 ↗MalfunctionJun 2, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE RECTUM, 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 25362229 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.