ECHELON ENDOPATHRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ECHELON ENDOPATH model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,543
- Deaths reported
- 39
- Injuries reported
- 536
- Recalls
- 2
We found 31 models of ECHELON ENDOPATH by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 6,543 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2015 and Sep 30, 2026 — classified as 39 deaths, 536 injuries, 5,968 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (2,680 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ECHELON ENDOPATH recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 22, 2025Open, Classified
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Z-1746-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 11, 2023Open, Classified
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Z-0834-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported ECHELON ENDOPATH problems
Device problems
- Failure to Form Staple2,680
- Failure to Fire1,253
- No Apparent Adverse Event657
- Difficult to Open or Close561
- Adverse Event Without Identified Device or Use Problem333
- Material Integrity Problem323
- Device Markings/Labelling Problem194
- Separation Problem141
Patient problems
- No Clinical Signs, Symptoms or Conditions4,573
- No Consequences Or Impact To Patient1,405
- Hemorrhage/Blood Loss/Bleeding378
- No Code Available158
- Failure to Anastomose129
- Blood Loss119
- Insufficient Information48
- Fistula46
ECHELON ENDOPATH models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Echelon Endopath GST60BSTAPLE, IMPLANTABLE8 deaths867 reports
- ECHELON ENDOPATH EC45ASTAPLE, IMPLANTABLE9 deaths753 reports
- ECHELON; ENDOPATH ECR60BSTAPLE, IMPLANTABLE1 death545 reports
- Echelon Endopath GST60GSTAPLE, IMPLANTABLE3 deaths521 reports
- Echelon Endopath GST60DSTAPLE, IMPLANTABLE1 death450 reports
- ECHELON; ENDOPATH ECR60DSTAPLE, IMPLANTABLE341 reports
- ECHELON; ENDOPATH ECR60GSTAPLE, IMPLANTABLE1 death317 reports
- Echelon Endopath VASECR35STAPLE, IMPLANTABLE1 recall1 death263 reports
- Echelon Endopath GST60WSTAPLE, IMPLANTABLE2 deaths294 reports
- ECHELON ENDOPATH GST45BSTAPLE, IMPLANTABLE5 deaths255 reports
- ECHELON ENDOPATH LONG60ASTAPLE, IMPLANTABLE2 deaths253 reports
- ECHELON ENDOPATH GST45WSTAPLE, IMPLANTABLE1 recall1 death163 reports
- ECHELON; ENDOPATH ECR45BSTAPLE, IMPLANTABLE2 deaths209 reports
- ECHELON ENDOPATH ECR60WSTAPLE, IMPLANTABLE1 death207 reports
- ECHELON ENDOPATH GST45GSTAPLE, IMPLANTABLE146 reports
- ECHELON ENDOPATH GST45DSTAPLE, IMPLANTABLE137 reports
- Echelon Endopath GST60TSTAPLE, IMPLANTABLE132 reports
- ECHELON ENDOPATH SC60ASTAPLE, IMPLANTABLE2 deaths120 reports
- ECHELON; ENDOPATH ECR45WSTAPLE, IMPLANTABLE117 reports
- ECHELON; ENDOPATH ECR45DSTAPLE, IMPLANTABLE115 reports
- ECHELON; ENDOPATH ECR45GSTAPLE, IMPLANTABLE109 reports
- ECHELON ENDOPATH SC45ASTAPLE, IMPLANTABLE63 reports
- ECHELON ENDOPATH EC60STAPLE, IMPLANTABLE55 reports
- ECHELON ENDOPATH GST45TSTAPLE, IMPLANTABLE43 reports
- ECHELON; ENDOPATH ECR45MSTAPLE, IMPLANTABLE28 reports
- ECHELON ENDOPATH EC45ALSTAPLE, IMPLANTABLE17 reports
- ECHELON ENDOPATH EC45STAPLE, IMPLANTABLE9 reports
- ECHELON ENDOPATH ECR60MSTAPLE, IMPLANTABLE6 reports
- ECHELON ENDOPATH SC60STAPLE, IMPLANTABLE5 reports
- ECHELON ENDOPATH ECR60TSTAPLE, IMPLANTABLE2 reports
- ECHELON ENDOPATH SC45STAPLE, IMPLANTABLE1 report
Recent ECHELON ENDOPATH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50948133 ↗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, 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 50921116 ↗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 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 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916695 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916647 ↗MalfunctionSep 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916392 ↗MalfunctionSep 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916336 ↗MalfunctionSep 28, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915789 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an unspecified surgical 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 50899548 ↗MalfunctionSep 25, 2026Failure to Form Staple; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50899296 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
- PROXIMATE41 models · 2,027 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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