ECHELON ENDOPATH ECR60MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705036013792), received between Dec 20, 2019 and Nov 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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, 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23523012 ↗
• MalfunctionMar 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN PERITONECTOMY PROCEDURE, A RELOAD WAS OPENED AND FOUND TO BE BENT/BROKEN. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949530 ↗
• MalfunctionAug 4, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN SEVERING VASCULAR TISSUE, AFTER FIRED, NOTED SOME STAPLES MALFORMED . 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 15167092 ↗
• MalfunctionMar 31, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE FARTHER AFTER FIRED 2/3. 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 13971529 ↗
• MalfunctionJan 8, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, UPON OPENING THE RELOAD, THE METAL TRAY ON THE RELOAD WAS NOTED TO BE DISLODGED FROM THE PLASTIC CARTRIDGE. A NEW RELOAD WAS OPENED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11142503 ↗
• MalfunctionDec 20, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ¿MD HAD USED SEVERAL GRAY ECHELON STAPLE RELOADS WITH THE POWERED ECHELON 60 STAPLER. WHEN SHE USED THE 5TH GRAY RELOAD, THAT WAS FROM A DIFFERENT LOT NUMBER FOR THE 4 PREVIOUS, IT MALFUNCTIONED. THE STAPLER FIRED NORMALLY, BUT THE STAPLE LINE WAS NOT SEALED FULLY WITH STAPLES. MD HAD TO QUICKLY USE SEVERAL HEMO-CLIPS ON THE VESSELS THAT WERE SPRAYING BLOOD. THIS COULD HAVE BEEN A VERY SERIOUS COMPLICATION HAD SHE NOT BEEN ABLE TO REACT QUICKLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505550 ↗