ECHELON ENDOPATH GST45DRecalls & 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 stapler is a single-use surgical instrument that cuts and staples tissue during endoscopic surgery. Of its 129 reports, 128 are malfunctions and 1 is an injury, with no deaths; many describe staples malformed after firing, and others describe the stapler not firing or parts coming loose. Reports fell to 23 in the last 12 months from 43 in the 12 months before. 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
- 137
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10705036014898), received between Jun 10, 2019 and Sep 28, 2026 — classified as 2 injuries, 135 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (60 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 Staple60
- Failure to Fire23
- Material Integrity Problem18
- No Apparent Adverse Event13
- Separation Problem11
- Ejection Problem8
- Delivered as Unsterile Product6
- Unintended Ejection6
Patient problems
- No Clinical Signs, Symptoms or Conditions130
- Hemorrhage/Blood Loss/Bleeding10
- No Consequences Or Impact To Patient4
- Failure to Anastomose2
- Foreign Body In Patient2
- Fistula1
- No Code Available1
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923771 ↗MalfunctionSep 28, 2026Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921779 ↗MalfunctionSep 28, 2026Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921772 ↗MalfunctionSep 28, 2026Manufacturing, Packaging or Shipping Problem
It was reported that, during an unknown respiratory surgery, the metal pan was damaged when the package was opened. The cartridge color was Gold. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920624 ↗MalfunctionSep 21, 2026Failure to Form Staple; No Apparent Adverse Event
It was reported that during an unknown surgery. It was observed that a few staples formed were with irregular shapes and anastomotic site was oozing. Changed to another one to continue the surgery but the same problem happened again. To stop oozing with compression hemostasis. There was no patient consequence reported. No additional information could be provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50842656 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834835 ↗MalfunctionSep 20, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834831 ↗InjurySep 18, 2026Detachment of Device or Device Component
It was reported that during a SADI-S (Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy procedure, a blue spec appeared after 3rd or 4th firing on the mid to proximal stomach. Stapler was fired again once after and acted as normal. Stapler sounded the same on the firing that left the blue spec. Blue spec was left in the patient. Additional information requested.
Patient problems: Foreign Body In Patient
MAUDE report 50825939 ↗MalfunctionSep 18, 2026Material Integrity Problem
It was reported that during an unknown procedure the reload broke. No patient or user harm or significant delay was reported. Additional information requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825525 ↗MalfunctionAug 26, 2026Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458936 ↗MalfunctionJun 8, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC RESPIRATORY SURGERY, IT WAS OBSERVED THAT THE KNIFE STOPPED MOVING ON THE WAY. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25433674 ↗MalfunctionMay 4, 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 25071719 ↗MalfunctionMay 4, 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 25071479 ↗MalfunctionApr 28, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SOME PARTS OF THE DEVICE CAME LOOSE AT THE TIME THE CARTRIDGE WAS OPENED; AND IT WAS POSSIBLE TO OBSERVE THAT IT WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017664 ↗MalfunctionApr 28, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SOME PARTS OF THE DEVICE CAME LOOSE AT THE TIME THE CARTRIDGE WAS OPENED; AND IT WAS POSSIBLE TO OBSERVE THAT IT WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017549 ↗MalfunctionApr 22, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A WEDGE PROCEDURE ON THE RIGHT UPPER LOBE, THE SURGEON FIRED TWO STAPLES WHERE ONE STAPLE SHOWED RUPTURED TISSUE AFTER FIRING WHILE THE OTHER ONE WAS MALFORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955957 ↗MalfunctionApr 22, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A WEDGE PROCEDURE ON THE RIGHT UPPER LOBE, THE SURGEON FIRED TWO STAPLES WHERE ONE STAPLE SHOWED RUPTURED TISSUE AFTER FIRING WHILE THE OTHER ONE WAS MALFORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955956 ↗MalfunctionApr 14, 2026Failure 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 24876575 ↗MalfunctionApr 13, 2026Ejection Problem
IT WAS REPORTED THAT DURING A BULLECTOMY PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE WAS NOT ASSEMBLED PROPERLY AND COULD NOT BE USED. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858996 ↗MalfunctionMar 20, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 24650005 ↗MalfunctionMar 9, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT SOME OF THE STAPLES DID NOT DEPLOY AND THE DEVICE STOPPED WHILE FIRING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548713 ↗MalfunctionFeb 6, 2026Failure 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 24282436 ↗MalfunctionFeb 5, 2026Material Integrity Problem; Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE AND THE METAL PART WERE NOT PROPERLY ATTACHED WHEN OPENED THE CARTRIDGE. ALSO, ONE SIDE OF THE TIP WAS BENT. ANOTHER CARTRIDGE WAS USED TO HANDLE THE SITUATION. EVEN AFTER ASKING THE DISTRIBUTION AGENCY AND THE OPERATING NURSE, THE OPERATION DATE AND THE SURGEON WERE UNKNOWN. THE DEVICE WAS NOT USED FOR THE PATIENT. THE CARTRIDGE COLOR WAS GOLD. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268352 ↗MalfunctionJan 29, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PART OF THE GOLD PLASTIC PART OF THE GST CARTRIDGE WAS CHIPPED AFTER FIRING. THE DEVICE WAS FIRED ON A PREVIOUS STAPLE LINE. THE FRAGMENTS WERE COLLECTED AND DISCARDED TO COMPLETE THE CASE. THE DEVICE WAS USED FOR INTERLOBAR FORMATION. THERE WAS NO EFFECT ON THE PATIENT. THE CARTRIDGE COLOR WAS GREEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24215379 ↗MalfunctionJan 22, 2026Failure to Fire
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION 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 24152253 ↗
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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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