ECHELON ENDOPATH GST45TRecalls & reported problems
Ethicon Endo-Surgery, LLC · The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired. · Class 2 · Implant
All models of ECHELON ENDOPATH (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Echelon Endopath GST45T is a disposable surgical stapler that cuts and staples tissue at the same time during minimally invasive surgery. The 38 reports mostly describe the stapler failing to fire or producing malformed staples, plus cartridges that would not seat properly or eject. One report describes a fistula and one describes bleeding. There were no deaths and 1 injury. No recalls name this device, and the report count was steady at 9 over each of the past two 12-month periods.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705036014911), received between Nov 26, 2018 and Sep 28, 2026 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (14 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 Fire14
- Failure to Form Staple11
- Material Integrity Problem6
- Device Markings/Labelling Problem5
- Ejection Problem4
- Difficult to Open or Close2
- Insufficient Device Problem Information2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient3
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916943 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916938 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834837 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834830 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834829 ↗MalfunctionJun 30, 2026No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT OOZING OCCURRED AFTER FIRING WHEN BOTH STAPLE LINE AND CUT LINE WERE COMPLETED. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. 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 25669225 ↗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 25335137 ↗MalfunctionApr 27, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A LOBECTOMY 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 WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001400 ↗MalfunctionApr 14, 2026Failure to Fire
IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE SURGEON HAD ALREADY FIRED WITH THE INSTRUMENT FIVE TIMES WITH NO ISSUES BUT AT THE SIXTH FIRING, THE BLADE CUT BUT THERE WERE NO CLIPS LIGATING THE TISSUE. THEY REPLACED THE DEVICE AND FINISHED THE OPERATION. THE TISSUE JUST NEEDED SUTURING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876433 ↗InjuryApr 2, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING A GASTROPLASTY THERE WAS AN OCCURRENCE OF A FISTULA IN PATIENT DURING A SLEEVE SURGERY AT THE FIRING OF THE FIRST STAPLE LOAD.
Patient problems: Fistula
MAUDE report 24764760 ↗MalfunctionJan 23, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN 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 24166843 ↗MalfunctionJan 7, 2026Material Integrity Problem; Ejection Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE DID NOT FIT INTO THE BODY SMOOTHLY AND SEEMS LIKE THE CARTRIDGE HAD BEEN DESTROYED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989770 ↗MalfunctionJan 2, 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 23945995 ↗MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE WAS DAMAGED. 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 23684182 ↗MalfunctionSep 19, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE FARTHER AFTER FIRED A LITTLE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096675 ↗MalfunctionAug 27, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN 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 22906607 ↗MalfunctionJul 30, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN 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 22666406 ↗MalfunctionJul 8, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A RESECTION OF THE PARENCHYMA IN LOBECTOMY, IT WAS OBSERVED THAT THE STAPLES AT OUTER 3 LINES OF THE TIP WERE UNFORMED AT THE 2ND FIRING. ANOTHER LIKE DEVICE WAS USED 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 22440103 ↗MalfunctionMay 1, 2025Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible
IT WAS REPORTED THAT DURING A THORACOSCOPIC SSEGMENTECTOMY PROCEDURE, IT WAS OBSERVED THAT WHEN THE CARTRIDGE WAS LOADED AND THE FIRING KNOB WAS PULLED TO TRY TO FIRE INTO THE LUNG PARENCHYMA, A SPINNING SOUND WAS HEARD AND THEN THE DEVICE STOPPED. THE STAPLES WERE NOT DEPLOYED AT ALL. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS WITH THE REPLACEMENT OF THE NEW CARTRIDGE. THE CARTRIDGE COLOR WAS BLACK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944483 ↗MalfunctionJan 28, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE NOTED THE STAPLES MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252419 ↗MalfunctionJan 13, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE LOCKED (STUCK) AFTER FIRING; AND COULD NOT BE USED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143371 ↗MalfunctionJan 7, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close
IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT IN THE COURSE OF A PROCEDURE USING THE PSEE60A, AN ERROR OCCURRED IN THE PROCESS OF FIRING. WHEN SURGEON PULLED BACK THE SAFETY LOCK AND FIRED THE TRIGGER, THE BLADE WAS SUDDENLY STOPPED IN THE MIDDLE OF CARTRIDGE. IT OCCURRED TWO MORE TIMES. AS AN EMERGENCY MEASURE, THE SURGEON BACKED OFF THE BLADE AND DETACHED IT FROM THE TISSUE. IT WAS FURTHER REPORTED THAT THE TROCAR HAD BEEN BENT WHEN IT WAS INSERTED INTO THE BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095291 ↗MalfunctionDec 30, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A RIGHT COLECTOMY PROCEDURE, IN THE COURSE OF A USING THE PSEE60A, AN ERROR OCCURRED IN THE PROCESS OF FIRING. WHEN SURGEON PULLED BACK THE SAFETY LOCK AND FIRED THE TRIGGER, THE BLADE WAS SUDDENLY STOPPED IN THE MIDDLE OF CARTRIDGE. AS AN EMERGENCY MEASURE, THE SURGEON BACKED OFF THE BLADE AND DETACH IT FROM THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21038221 ↗MalfunctionOct 30, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING LAPAROSCOPIC LOBECTOMY SURGERY, THE DEVICE COULD NOT FIRE FARTHER AFTER FIRED A LITTLE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566567 ↗MalfunctionOct 29, 2024Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information
AFTER 3 RELOAD APPLIED, THE SURGEON FOUND THE FRAGMENT WHICH MAY COME FROM RELOAD IN THE PATIENT BODY. SO, THEY PICK THE FRAGMENT UP. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559998 ↗
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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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