Echelon Linear Cutter GLCR80BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036027898), received between Dec 13, 2024 and Apr 16, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K223760); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, COULD NOT FIRE. 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 24899806 ↗
• MalfunctionApr 11, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, A REPORT WAS RECEIVED THAT FIRING COULD NOT BE PERFORMED WITH THE GLC. WHEN THE SALES REP ARRIVED AT THE OPERATING ROOM, TWO CARTRIDGES WERE COLLECTED, ONE CARTRIDGE WAS USED AND ANOTHER CARTRIDGE COULD NOT BE FIRED. THEREFORE, ONE OF THE CARTRIDGES WAS NOT DEFECTIVE. FOR DEFECTIVE CARTRIDGE, THE ORANGE BAR AT THE PROXIMAL END WAS NOT OPEN, BUT PARTIAL STAPLE DEPLOYMENT WAS OBSERVED. THE NURSE CONFIRMED THAT THE CARTRIDGE WAS ATTACHED FROM THE HEAD PART AS USUAL. THE CARTRIDGE COLOR WAS BLUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847513 ↗
• MalfunctionFeb 27, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE CARTRIDGE WAS REPLACED DUE TO THE DEVICE COULD NOT BE FIRED. THE STAPLES HAD SLIGHTLY COME OUT. THE CARTRIDGE COLOR WAS BLUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472907 ↗
• InjuryFeb 3, 2025Structural Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Structural Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE SALES REP THAT POST OP OF A RIGHT COLON PROCEDURE, THE SURGEON STATES HE'S HAD A LEAK. PATIENT HAD TO BE BROUGHT BACK. THE LEAK WAS AT THE STAPLE LINE.

  Patient problems: Abdominal Pain; Failure to Anastomose

  MAUDE report 21291808 ↗
• MalfunctionDec 13, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT ON THE 2ND FIRE THE STAPLE LINE FELL APART AT THE VERY END OF THE STAPLE LINE. THE FIRST FIRE WAS GOOD AND THE THIRD FIRE WAS GOOD. THEY ALL HAVE THE SAME LOT NUMBER. THE SURGEON USED THE SILK SUTURE TO OVER SEW THE ANASTOMOSIS. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223760. One submission often covers many models, so check the product and lot details in each record.

• Z-0147-2026 · Sep 11, 2025 · Open, Classified
  ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80