ECHELON FLEXRecalls & 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
- 9,393
- Deaths reported
- 59
- Injuries reported
- 1,151
- Recalls
- 1
We found 7 models of ECHELON FLEX by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 9,393 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2016 and Sep 30, 2026 — classified as 59 deaths, 1,151 injuries, 8,183 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (3,014 reports).
1 FDA recall record name at least one of these models by its device identifier.
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 FLEX 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.
- Jun 3, 2021Terminated
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Z-2326-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported ECHELON FLEX problems
Device problems
- Failure to Fire3,014
- Difficult to Open or Close2,700
- Failure to Form Staple1,688
- Mechanical Jam1,002
- Adverse Event Without Identified Device or Use Problem756
- Activation Failure586
- No Apparent Adverse Event459
- Material Integrity Problem366
Patient problems
- No Clinical Signs, Symptoms or Conditions6,038
- No Consequences Or Impact To Patient2,125
- Hemorrhage/Blood Loss/Bleeding645
- No Code Available361
- Failure to Anastomose280
- Blood Loss263
- Insufficient Information104
- Unspecified Tissue Injury73
ECHELON FLEX models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ECHELON FLEX PSEE60ASTAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- ECHELON FLEX PVE35ASTAPLE, IMPLANTABLE29 deaths1,880 reports
- ECHELON FLEX PLEE60ASTAPLE, IMPLANTABLE6 deaths1,786 reports
- ECHELON FLEX PSEE45ASTAPLE, IMPLANTABLE5 deaths1,258 reports
- ECHELON FLEX PCEE60ASTAPLE, IMPLANTABLE3 deaths689 reports
- ECHELON FLEX PCEE45ASTAPLE, IMPLANTABLE1 death390 reports
- ECHELON FLEX PLEE45ASTAPLE, IMPLANTABLE2 deaths96 reports
Recent ECHELON FLEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952156 ↗MalfunctionSep 30, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951524 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia
MAUDE report 50948834 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia
MAUDE report 50948824 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia
MAUDE report 50948816 ↗MalfunctionSep 30, 2026Difficult to Open or Close; No Apparent Adverse Event; Activation Failure; Activation Problem
It was reported that during a Liver Transplant procedure, the device was fired and subsequently jammed in the closed position, preventing the jaws from being opened. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 50947554 ↗MalfunctionSep 28, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923188 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920335 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920167 ↗InjurySep 28, 2026Insufficient Device Problem Information; Noise, Audible
Patient problems: Insufficient Information
MAUDE report 50919812 ↗MalfunctionSep 28, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919465 ↗MalfunctionSep 28, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919308 ↗MalfunctionSep 28, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919025 ↗MalfunctionSep 28, 2026Failure to Form Staple; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917225 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917131 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- 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
- 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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