ENDOPATHRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,785
- Deaths reported
- 3
- Injuries reported
- 157
- Recalls
- 0
We found 37 models of ENDOPATH by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 2,785 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2015 and Sep 28, 2026 — classified as 3 deaths, 157 injuries, 2,624 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (1,037 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 ENDOPATH problems
Device problems
- Failure to Fire1,037
- Difficult to Open or Close383
- Failure to Form Staple304
- Detachment of Device or Device Component149
- Insufficient Device Problem Information140
- Firing Problem137
- Failure to Cut125
- Mechanical Jam110
Patient problems
- No Clinical Signs, Symptoms or Conditions1,400
- No Consequences Or Impact To Patient1,200
- Hemorrhage/Blood Loss/Bleeding51
- No Code Available48
- Insufficient Information32
- Blood Loss29
- Unspecified Tissue Injury22
- Failure to Anastomose17
ENDOPATH models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOPATH ATS45STAPLE, IMPLANTABLE2 deaths2,046 reports
- ENDOPATH EPS03Electrosurgical, cutting & coagulation & accessories109 reports
- ENDOPATH 5DCSELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES93 reports
- ENDOPATH TR45WSTAPLE, IMPLANTABLE63 reports
- ENDOPATH ATS45NKSTAPLE, IMPLANTABLE49 reports
- ENDOPATH 6R45BSTAPLE, IMPLANTABLE47 reports
- ENDOPATH TT012CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY47 reports
- Endopath PN120APPARATUS, PNEUMOPERITONEUM, AUTOMATIC1 death36 reports
- ENDOPATH BCD10INSTRUMENT, MANUAL, SURGICAL, GENERAL USE30 reports
- ENDOPATH EPS01Electrosurgical, cutting & coagulation & accessories30 reports
- ENDOPATH EPS06Electrosurgical, cutting & coagulation & accessories30 reports
- ENDOPATH 5DCDELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES25 reports
- ENDOPATH EPS02Electrosurgical, cutting & coagulation & accessories24 reports
- ENDOPATH UV120INSUFFLATOR, LAPAROSCOPIC24 reports
- ENDOPATH EPH02Electrosurgical, cutting & coagulation & accessories20 reports
- ENDOPATH EPS07Electrosurgical, cutting & coagulation & accessories17 reports
- Endopath PN150APPARATUS, PNEUMOPERITONEUM, AUTOMATIC14 reports
- ENDOPATH 23NBSLaparoscope, general & plastic surgery10 reports
- ENDOPATH EPH04Electrosurgical, cutting & coagulation & accessories10 reports
- ENDOPATH 5BBINSTRUMENT, MANUAL, SURGICAL, GENERAL USE9 reports
- ENDOPATH 5DSGINSTRUMENT, MANUAL, SURGICAL, GENERAL USE8 reports
- ENDOPATH BTD05INSTRUMENT, MANUAL, SURGICAL, GENERAL USE7 reports
- ENDOPATH 6TB45STAPLE, IMPLANTABLE5 reports
- ENDOPATH ATW35STAPLE, IMPLANTABLE5 reports
- ENDOPATH EPS05Electrosurgical, cutting & coagulation & accessories4 reports
- ENDOPATH ATG45STAPLE, IMPLANTABLE4 reports
- ENDOPATH ATW45STAPLE, IMPLANTABLE4 reports
- ENDOPATH TR45GSTAPLE, IMPLANTABLE3 reports
- ENDOPATH 10AGINSTRUMENT, MANUAL, SURGICAL, GENERAL USE2 reports
- ENDOPATH EBF01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- ENDOPATH TSB35STAPLE, IMPLANTABLE2 reports
- ENDOPATH 23NBLLaparoscope, general & plastic surgery1 report
- ENDOPATH EPS04Electrosurgical, cutting & coagulation & accessories1 report
- ENDOPATH LONG45ASTAPLE, IMPLANTABLE1 report
- ENDOPATH TR35WSTAPLE, IMPLANTABLE1 report
- ENDOPATH ATB35STAPLE, IMPLANTABLE1 report
- ENDOPATH TSW35STAPLE, IMPLANTABLE1 report
Recent 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 Cut; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923748 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916582 ↗MalfunctionSep 24, 2026Failure to Fire; Noise, Audible
It was reported that during a Laparoscopic Appendectomy procedure, it was observed that the stapler was loud when firing; and the surgeon was only able to fire half of the staple load. There was no patient consequence nor surgical delay reported. Additional information requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882238 ↗MalfunctionSep 21, 2026Failure to Cut; Firing Problem
It was reported that during an unknown procedure, the device attached the white cartridge and tried to fire, but the knife was too hard to move halfway through. The blue cartridge was used and the device could be fired. The cartridge colors were white and bule. Another cartridge was loaded into the same device to complete the case. There were no adverse consequences to the patient. Additional information requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840830 ↗MalfunctionSep 17, 2026Failure to Form Staple; No Apparent Adverse Event
It was reported that during an unknown procedure, it was observed that the staple line did not close properly, causing bleeding in the intra-op, forcing the surgeon to perform cecal appendix raffia. The patient recovered from the procedure and is now well, with no further information. No additional information provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50804125 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569742 ↗InjurySep 2, 2026Insufficient Device Problem Information; Patient Device Interaction Problem
It was reported that, during a total laparoscopic hysterectomy with bilateral salpingectomy for uterine fibroids, bleeding from the port site was cauterized using a right-angle electrode of the Probe Plus during wound closure. An electric current ran through the muscle retractor that was placed in the surgical field at that time, causing a second-degree burn. The attending physician's opinion is that it may have been an electrical discharge. The patient is female, but it is currently confirming the treatment she received for this incident, her condition after treatment, and the patient background information. No further information is available.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 50255379 ↗MalfunctionAug 24, 2026Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411803 ↗MalfunctionAug 17, 2026Difficult to Open or Close; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286745 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258426 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255749 ↗InjuryAug 14, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 50255335 ↗MalfunctionAug 12, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220387 ↗MalfunctionJul 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100963 ↗MalfunctionJul 27, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037742 ↗
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
- 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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