ECHELON ENDOPATH GST45GRecalls & 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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Echelon Endopath stapler has 144 FDA adverse event reports, with no deaths and 9 injuries. Many describe staples not forming properly or the stapler failing to fire, and some mention bleeding at the stapled area. Most patients showed no clinical signs. 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
- 146
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 10705036014904), received between Feb 2, 2018 and Sep 21, 2026 — classified as 9 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (48 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple48
- Failure to Fire27
- Material Integrity Problem25
- Separation Problem14
- No Apparent Adverse Event12
- Ejection Problem11
- Adverse Event Without Identified Device or Use Problem10
- Unintended Ejection7
Patient problems
- No Clinical Signs, Symptoms or Conditions130
- Hemorrhage/Blood Loss/Bleeding16
- No Consequences Or Impact To Patient5
- Foreign Body In Patient2
- No Code Available1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.
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 50842655 ↗MalfunctionSep 1, 2026Failure to Form Staple
It was reported that during an Unknown surgery, after fired, noted the staples malformed. Suture was used to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543937 ↗MalfunctionAug 17, 2026Unintended Ejection; Material Integrity Problem; Separation Problem
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50286707 ↗MalfunctionJul 20, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873754 ↗MalfunctionJun 9, 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 25443650 ↗MalfunctionJun 2, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE STAPLE LINE AND CUT LINE HAD OOZING AFTER THEY WERE COMPLETED. THEY STOPPED OOZING WITH COMPRESSION HEMOSTASIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 25363225 ↗MalfunctionJun 1, 2026Separation Problem
IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ALUMINUM PART AT THE BOTTOM OF THE DEVICE WAS BENT AND DEFORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355535 ↗MalfunctionMay 28, 2026Unintended Ejection
IT WAS REPORTED THAT DURING A THORACOSCOPIC. SEGMENTECTOMY, WHEN THE GST45G CARTRIDGE WAS ATTACHED TO THE PCEE45A, THE CARTRIDGE FELT LOOSER THAN USUAL WHEN LOADED. JUST IN CASE, THE CARTRIDGE WAS REPLACED WITH ANOTHER CARTRIDGE AND THE SURGERY WAS CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CARTRIDGE COLOR WAS GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319820 ↗MalfunctionMay 28, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A RESECTION OF LUNG TUMORS 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 25319581 ↗MalfunctionMar 31, 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 24746473 ↗MalfunctionFeb 17, 2026Structural Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE PLASTIC PART ON THE CARTRIDGE WAS DIVIDED WHEN THEY OPENED ITS PACKAGE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367748 ↗MalfunctionFeb 9, 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 24298465 ↗MalfunctionJan 23, 2026No Apparent Adverse Event
IT WAS REPORTED THAT DURING A LAP GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THERE WAS OOZING AFTER FIRING WHEN BOTH STAPLE AND CUT LINES WERE COMPLETE. 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 24166603 ↗MalfunctionJan 12, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 24035531 ↗MalfunctionJan 7, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PART OF THE GREEN 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 23994059 ↗MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT A FEW STAPLES WERE FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING AFTER FIRING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803299 ↗MalfunctionDec 1, 2025Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE MAGAZINES DID NOT HOLD/STAY IN THE DEVICE; AND THAT IT WOULD SLIDE OUT FORWARD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687193 ↗MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658209 ↗MalfunctionNov 26, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657744 ↗MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED BY THE KEY ACCOUNT MANAGER THAT THE CLINIC RECEIVED BATCHES OF PRODUCTS (SPECIFIED IN THE CONTRACT AS ETHICON PRODUCTS) THAT WERE NOT SHIPPED TO OUR WAREHOUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657202 ↗MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED BY THE KEY ACCOUNT MANAGER THAT THE CLINIC RECEIVED BATCHES OF PRODUCTS (SPECIFIED IN THE CONTRACT AS ETHICON PRODUCTS) THAT WERE NOT SHIPPED TO OUR WAREHOUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657196 ↗MalfunctionNov 11, 2025No Apparent Adverse Event; No 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 23522815 ↗MalfunctionOct 31, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED. 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 PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439372 ↗MalfunctionOct 27, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER CARTRIDGE GOT STUCK HALFWAY AND COULD NOT ADVANCE FURTHER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395488 ↗MalfunctionOct 27, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT DURING AN ANTERIOR RECTAL RESECTION PROCEDURE, THE 45 MM ECHELON FLEX¿ POWER MECHANICAL SUTURE WAS USED FOLLOWING ALL APPROPRIATE INDICATIONS FOR USE. IT WORKED SUCCESSFULLY IN THREE SHOTS. IN THE FOURTH SHOT, A REFILL WAS USED AND, AFTER MAKING THE SHOT AND REMOVING THE DEVICE, IT WAS EVIDENT THAT IT WAS COMPLETELY DISASSEMBLED: THE METAL PART WAS SEPARATED FROM THE OTHER COMPONENT AND THE PUSHER CART ALSO CAME OUT OF THE REFILL. THEY REMOVED ALL PARTS OF THE RELOAD TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392384 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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