Echelon Linear Cutter GLC60Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036030874), received between Jan 3, 2025 and Sep 16, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that during the revision surgery, his counterpart used GLC and the staple line opened up again. They did another revision and hand tied the anastomosis this time. The GLC was used on the revision on (b)(6) and then that staple line opened up so they needed to do another revision, which they hand tied the anastomosis with suture rather than stapling a third time.

  Patient problems: Failure to Anastomose

  MAUDE report 50793807 ↗
• MalfunctionAug 17, 2026Failure to Fire

  It was reported that during an Unknown surgery, no staples deployed. Suture was used to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276607 ↗
• MalfunctionMay 7, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THEY HAVE ISSUES WITH 2 GLC60 DEVICES. THE FIRST ISSUE WAS THE DEVICE WOULD NOT OPEN. THE SECOND ISSUE WAS THE DEVICE WOULD NOT CLOSE. BOTH DEVICES WERE NOT FIRED AND THE SURGEON USED A DIFFERENT DEVICE INSTEAD. NO PATIENT HARM REPORTED. HAPPENED ROUGHLY 3 WEEKS AGO BUT SPECIFIC DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117329 ↗
• MalfunctionApr 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, ECHELON LINEAR CUTTER GLC60 WERE BROKE AFTER OPEN THE INSTRUMENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001622 ↗
• MalfunctionMar 25, 2026Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK SURGERY, WE ENCOUNTER SEVERAL PROBLEMS WITH THIS CLAMP: THE CLAMP DOES NOT CLOSE, SEVERAL STAPLES ARE IN THE SAME PLACE. WE CHANGED THE CLAMP AND CHARGERS AND THE PROBLEM PERSISTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690812 ↗
• MalfunctionFeb 26, 2026Failure to Cut

  IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION PROCEDURE, THE STAPLER FAILED TO CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456137 ↗
• MalfunctionSep 15, 2025Difficult to Insert; Firing Problem; Difficult to Insert; Firing Problem

  IT WAS REPORTED THAT DURING A TUMOR RESECTION THE RELOAD FELL FROM THE LINEAR SUTURE LINE. CHANGE THE DEVICE AND RELOAD, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED, ONLY THAT THE RELOAD FELL OFF THE LINEAR CUTTER. THE HOSPITAL CHANGED THE DEVICE AND RELOAD, THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053313 ↗
• InjuryJan 3, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABDOMINAL PERITONEUM UPON FIRING THE DEVICE FOR AN ENTEROTOMY CLOSURE DURING A SIDE TO SIDE ANASTOMOSES, HE NOTICED THERE WAS A HOLE ON THE OPPOSITE SIDE OF THE ENTEROTOMY. THIS NEEDED TO BE MANUALLY CLOSED WITH SUTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY MINUTES. PATIENT CONSEQUENCES UNKNOWN.

  Patient problems: Failure to Anastomose

  MAUDE report 21070376 ↗

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