ECHELON ENDOPATH ECR60TRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Linear Cutter Reloads Black 4.4mm, 6 rows · Class 2 · Implant
All models of ECHELON ENDOPATH (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705036014369), received between Oct 22, 2021 and Jun 16, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient Device Interaction Problem1
Patient problems
- Cancer2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ¿I HAD ENDOSCOPIC GASTRIC SLEEVE SURGERY. SURGEON USED ETHICON ECHELON ENDOCUTTER BLACK MODEL ECR60T. I HAD STAPLE LINE LEAK AND ENDED UP HAVING THREE ORGANS REMOVED AND NOW HAVE LEUKEMIA. I DIDN'T KNOW THE PRODUCT WAS ON A FDS RECALL.¿
Patient problems: Cancer
MAUDE report 14712010 ↗InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD SURGERY IN 2016. SHE WAS INQUIRING ABOUT ECR60T WHICH WAS USED IN HER SURGERY AND WANTED TO KNOW WHICH LOT NUMBER SHE HAS IMPLANTED IN HER. PATIENT STATES THAT SHE HAS SINCE HAD TO HAVE HER STOMACH REMOVED AND IS VERY SICK. PATIENT STATES THAT SHE IS A SINGLE MOM, HAS CANCER AND IS VERY SICK.
Patient problems: Cancer; Insufficient Information
MAUDE report 12683579 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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