ECHELON; ENDOPATH ECR60GRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Linear Cutter Reloads Green 4.1 mm, 6 rows · Class 2 · Implant
Quick summary
This Ethicon Echelon staple reload is a cartridge of staples for a surgical stapler. Of its 319 reports, 294 are malfunctions and 24 are injuries, mostly describing staples that do not form, the stapler failing to fire, and staple parts falling out during loading. Most reports describe no patient effect. The reports mention 1 death. No recalls name this device. Reports fell to 18 in the last 12 months from 38 in the previous 12.
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
- 317
- Deaths reported
- 1
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 317 adverse event reports that list this exact device (DI 10705036001782), received between Nov 29, 2017 and Aug 31, 2026 — classified as 1 death, 24 injuries, 292 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (151 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 Staple151
- Failure to Fire66
- Material Integrity Problem24
- Adverse Event Without Identified Device or Use Problem21
- No Apparent Adverse Event13
- Separation Problem10
- Manufacturing, Packaging or Shipping Problem7
- Device Misassembled During Manufacturing /Shipping4
Patient problems
- No Clinical Signs, Symptoms or Conditions209
- No Consequences Or Impact To Patient81
- Failure to Anastomose15
- Hemorrhage/Blood Loss/Bleeding14
- No Code Available9
- Blood Loss8
- Dyspnea3
- Fistula2
Recent adverse event reports
The 25 most recent of 317 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Failure to Form Staple; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50520995 ↗MalfunctionAug 25, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433014 ↗MalfunctionJul 1, 2026Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT BEFORE USING ON PATIENT, FOR AN UNKNOWN PROCEDURE, OPEN THE PACKING AND NOTED THAT THE STAPLE DRIVERS FELL OFF . 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 25678447 ↗MalfunctionJun 30, 2026Structural Problem
IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, WHILE THE NURSE WAS LOADING THE ECR60G INTO THE STAPLER, THE INNER STAPLES OF THE ECR60G FELL OUT OF THEIR POCKETS. THEY REMOVED THE RELOAD AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669288 ↗MalfunctionMay 5, 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 25083024 ↗MalfunctionApr 13, 2026Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A STAPLE REFILL WAS USED AND THE METAL PARTS OF THE LOADER MOVED APART, THE LOADER JAWS WERE SHREDDED, AND A MOVABLE ELEMENT BECAME DETACHED. THE STAPLE FEEDER HAD BEEN USED WITH THE ECHELON 3000 CLAMP, WHICH SHOWED NO PROBLEM AND FUNCTIONED NORMALLY WITH OTHER STAPLE FEEDERS AFTERWARD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860488 ↗MalfunctionMar 26, 2026Failure to Fire
IT WAS REPORTED THAT THE DEVICE MISFIRED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699996 ↗MalfunctionFeb 11, 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 24315029 ↗MalfunctionFeb 11, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, COULD NOT FIRE. 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 24314762 ↗MalfunctionJan 26, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AND 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 24177621 ↗MalfunctionJan 7, 2026Separation Problem
IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE METAL PART OF CARTRIDGE WAS DEFORMED UPON OPENING ITS PACKAGE. 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 23993947 ↗MalfunctionJan 7, 2026Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THERE WAS CARTRIDGE PAN SEPARATION AFTER OPENING THE PACKING. 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 23990191 ↗MalfunctionDec 15, 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 23810600 ↗MalfunctionDec 4, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE METAL PART OF THE CARTRIDGE WAS DEFORMED UPON OPENING ITS PACKAGE. 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 23716380 ↗MalfunctionNov 11, 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 23525747 ↗MalfunctionNov 11, 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 23525657 ↗MalfunctionOct 27, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LUNG RESECTION 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 23397017 ↗MalfunctionOct 27, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LUNG RESECTION 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 23396883 ↗MalfunctionOct 27, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LUNG RESECTION 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 23396728 ↗MalfunctionSep 5, 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 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22980037 ↗MalfunctionSep 5, 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 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22980036 ↗MalfunctionSep 5, 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 22979465 ↗MalfunctionAug 20, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A GASTRECTOMY 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 22850487 ↗MalfunctionAug 20, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A DISTAL GASTRECTOMY PROCEDURE; IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED. 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 22849889 ↗MalfunctionJul 28, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, IT WAS OBSERVED THAT THE METAL PART OF THE RELOAD REMAINED IN THE STAPLER WHEN REMOVING IT. THEY HAD TO USE A TWEEZER TO REMOVE IT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630521 ↗
Other STAPLE, IMPLANTABLE devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.