ECHELON Flex ENDOPATHRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,334
- Deaths reported
- 13
- Injuries reported
- 233
- Recalls
- 0
We found 7 models of ECHELON Flex ENDOPATH by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 2,334 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2013 and Sep 28, 2026 — classified as 13 deaths, 233 injuries, 2,088 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (710 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. 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
Most reported ECHELON Flex ENDOPATH problems
Device problems
- Failure to Fire710
- Difficult to Open or Close679
- Failure to Form Staple535
- Mechanical Jam190
- Retraction Problem115
- Adverse Event Without Identified Device or Use Problem109
- Mechanical Problem89
- No Apparent Adverse Event76
Patient problems
- No Clinical Signs, Symptoms or Conditions1,227
- No Consequences Or Impact To Patient856
- No Code Available101
- Hemorrhage/Blood Loss/Bleeding81
- Blood Loss48
- Failure to Anastomose48
- Insufficient Information32
- Unspecified Tissue Injury26
ECHELON Flex ENDOPATH models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ECHELON FLEX ENDOPATH EC60ASTAPLE, IMPLANTABLE8 deaths1,450 reports
- ECHELON Flex ENDOPATH PSE45ASTAPLE, IMPLANTABLE1 death384 reports
- ECHELON Flex ENDOPATH PSE60ASTAPLE, IMPLANTABLE3 deaths329 reports
- ECHELON Flex ENDOPATH PCE60ASTAPLE, IMPLANTABLE53 reports
- ECHELON Flex ENDOPATH PCE45ASTAPLE, IMPLANTABLE1 death50 reports
- ECHELON Flex ENDOPATH PLE60ASTAPLE, IMPLANTABLE46 reports
- ECHELON Flex ENDOPATH PLE45ASTAPLE, IMPLANTABLE22 reports
Recent ECHELON Flex ENDOPATH adverse event reports
The 15 most recent reports across all models, 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 50922225 ↗MalfunctionSep 24, 2026Failure to Form Staple
It was reported that during an unknown procedure, it was observed that some staples were malformed with irregular shape after firing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884269 ↗MalfunctionSep 24, 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 50883667 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during an unknown procedure, it was observed that the staples were malformed after firing. Changed another one to continue the surgery, the same problem happened again. 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 50840904 ↗MalfunctionSep 18, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829278 ↗MalfunctionSep 17, 2026Failure to Cut; Difficult to Open or Close; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807772 ↗MalfunctionSep 17, 2026Failure to Cut; Difficult to Open or Close
It was reported that during a Gastroplasty procedure, it was observed that the device had an unspecified malfunction. There was no patient consequence nor surgical delay reported. Additional information requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807215 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50572052 ↗MalfunctionAug 31, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520037 ↗MalfunctionAug 24, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412889 ↗MalfunctionAug 24, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409591 ↗MalfunctionAug 14, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260359 ↗MalfunctionAug 14, 2026Failure to Form Staple; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256259 ↗MalfunctionAug 14, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254402 ↗MalfunctionAug 10, 2026Insufficient Device Problem Information
It was reported that during an unknown procedure, it was observed that the stapler misfired. 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 50195193 ↗
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
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 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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