Echelon Linear Cutter GLC80Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10705036030881), received between Aug 21, 2024 and Sep 22, 2026 — classified as 2 deaths, 24 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (25 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 11, 2025Open, Classified

   The devices were shipped unsterilized.

   Z-0147-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857300 ↗
• MalfunctionSep 17, 2026Unintended Compatibility

  It was reported that during an Unknown procedure the GLC Linear cutter broke from the Anvil part. Unable to fire the cartridge.Was there any reported patient or user harm? No. Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802482 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50793750 ↗
• MalfunctionSep 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50761710 ↗
• MalfunctionSep 2, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563618 ↗
• MalfunctionAug 18, 2026Failure to Cut; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302251 ↗
• MalfunctionAug 18, 2026Structural Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301009 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the product used was a GLC80 with a blue reload. It was used to resect a portion of the small bowel in an emergency procedure. There were no issues during the procedure and recovery for the first 6 days was as expected. However the surgeon emailed to say the patient had a small bowel tumour resection with Barcelona type anastomosis. Proven bleed from anastomosis on CT angiogram- self limiting however. Patient came back into hospital and had to have a blood transfusion. The patient has recovered.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 50097822 ↗
• MalfunctionJul 13, 2026Failure to Fire; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798977 ↗
• MalfunctionJul 8, 2026Material Integrity Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748774 ↗
• MalfunctionJul 7, 2026Failure to Fire; Mechanical Jam; Unintended Compatibility

  IT WAS REPORTED THAT DURING A COLON RESECTION THE STAPLE LINE HAD STAPLED TISSUE NEEDED IN THE END THE ODP SAID THAT THE SURGEON FIRST STRUGGLED TO PUT THE DEVICE TOGETHER WHEN FIRING AS THE GREY FIRING KNOB WAS NOT IN THE HOME POSITION. HE WAS THEN STAPLING THE BOWEL USING THE TROUSER LEG TECHNIQUE AND SAID THAT IT LOOKED LIKE THE STAPLES HADN¿T FIRED AT THE PROXIMAL END BUT HAD DONE AT THE DISTAL END. HOWEVER AS THE BOWEL WAS PLACED AT THE PROXIMAL END IT COMPLETED THE TRANSECTION NEEDED. NO HARM TO THE PATIENT ALTHOUGH THE SURGEON DID STRUGGLE TO USE THE TA90 STAPLER FOR THE CROSS FIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736503 ↗
• MalfunctionJun 18, 2026Firing Problem

  IT WAS REPORTED THAT DURING A LAPAROTOMY, WENT THROUGH SEVERAL GLC DEVICES AND RELOADS AND COMPLAINED OF DIFFICULTY FIRING/ MISFIRING ON AN OPEN LAPAROTOMY/ TRAUMA GUN SHOT CASE. PROCEDURE WAS DELAYED BY 15 MINUTES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548952 ↗
• MalfunctionMay 26, 2026Firing Problem

  IT WAS REPORTED THAT, DURING SMALL BOWEL RESECTION SURGERY, WHEN THE LINEAR CUTTER WAS ATTEMPTED TO FIRE, THE KNOB FELT STIFF AND DID NOT ADVANCE DESPITE APPLYING FORCE. WHEN CHECKING THE DEVICE AFTER THAT, A CRACK WAS FOUND NEAR THE BASE OF THE ANVIL, SO ANOTHER DEVICE WAS USED. ANOTHER DEVICE FUNCTIONED NORMALLY. 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 25278572 ↗
• MalfunctionMay 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE 'FELL TO PIECES' WHEN CLAMPING IN TISSUE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270458 ↗
• MalfunctionMay 23, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CIRCULATOR SAID THE STAPLER GOT STUCK CLOSED. THE SURGEONS COULDN'T OPEN IT BACK UP AFTER IT WAS OUT AND OFF THE PATIENT. THERE WAS A 5MIN OF SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264724 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ELECTIVE LAP RIGHT HEMICOLECTOMIE PROCEDURE, PATIENT WAS READMITTED TO HOSPITAL 3 DAYS POST OP WITH RAISED CRP MARKERS. WHEN THEY WERE CT SCANNED THERE WERE BUBBLES AROUND THE STAPLE LINE.

  Patient problems: Failure to Anastomose

  MAUDE report 25184626 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, IN THE MIDDLE OF THE NIGHT THE SURGEON WAS MAKING THE ANASTOMOSIS USING THE BARCELONA TECHNIQUE. HE JOINED THE COLON TO THE SMALL BOWEL WITH ONE FIRING USING A BLUE RELOAD AND THEN SUTURED THE OTOMY. THE PATIENT LEAKED AND HAD TO BE BROUGHT BACK TO THEATRE.

  Patient problems: Failure to Anastomose

  MAUDE report 25165267 ↗
• MalfunctionMay 12, 2026Failure to Cut

  IT WAS REPORTED THAT DURING COLORECTAL PROCEDURE THE SURGEON ATTEMPTED TO STAPLE THE INCISION; HOWEVER, THE STAPLER DID NOT CUT COMPLETELY THROUGH THE TISSUE, LEAVING APPROXIMATELY 2 CM UNCUT AT THE END OF THE STAPLE LINE. THERE WERE NO PATIENT CONSEQUENCES OR ADVERSE OUTCOMES. A NEW STAPLER WAS OBTAINED, AND THE SURGEON SUCCESSFULLY COMPLETED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154525 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ELECTIVE RIGHT HEMI IN AN ELDERLY MAN USING THE GLC80 AND A BLUE RELOAD. THE SURGEON MADE THE ANASTOMOSIS USING THE BARCELONA TECHNIQUE, ALL LOOKED NORMAL, PATIENT WAS CLOSED AND NO COMPLICATIONS EXPECTED. THAT NIGHT THE PATIENT SUFFERED A CATASTROPHIC BLEED FROM THE STAPLE LINE AND HAD TO BE RESUSCITATED. THE SITUATION IS STILL EMERGING, AS TO IF FURTHER INTERVENTIONS ARE NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25119093 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLE WAS OBSERVED TO BE MALFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114340 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER THE FIRST STAPLING THE ECHELON CLAMP BROKE. THE TWO SMALL METAL PIECES FELL. A PLASTIC TIE HAS CRACKED. THE USE WAS MADE ACCORDING TO THE MANUFACTURER¿S RECOMMENDATIONS BY AN EXPERIENCED SURGEON. THE ANASTOMOSIS HAD TO BE REDONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086855 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, DR. SAYS THAT AT THE THIRD SHOT, WHEN CLOSING THE JAWS, A WHITE PIECE WAS RELEASED AND THE DEVICE WAS DISASSEMBLED, LEAVING THE YELLOW COVER LOOSE. A NEW PRODUCT AND NEW REFILL MUST BE USED. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981389 ↗
• MalfunctionApr 14, 2026Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873311 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BENSHABAT E, YUVAL JB, LEIBOVITZH H, HIRSCH A, LAHAT G, KARIV Y, ZEMEL M. COMPARING PERIOPERATIVE OUTCOMES OF STAPLED VERSUS HANDSEWN KONO-S ANASTOMOSIS AFTER ILEOCOLONIC RESECTION FOR CROHN'S DISEASE. TECH COLOPROCTOL. 2025 OCT 16;29(1):182. DOI: 10.1007/S10151-025-03219-Y. PMID: 41099860; PMCID: PMC12532619. THE AIM OF THE STUDY IS TO COMPARE THE OPERATIVE TIME AND PERIO PERATIVE OUTCOMES OF STAPLED VERSUS HANDSEWN KONO-S ILEOCOLONIC ANASTOMOSIS IN PATIENTS WITH CD. THIS WAS A SINGLE-CENTER, OBSERVATIONAL COHORT STUDY. THE STUDY INCLUDED ALL CONSECUTIVE PATIENTS WITH A CONFIRMED DIAGNOSIS OF CD, WHO UNDERWENT AN ANTIMESENTERIC FUNCTIONAL END-TO-END KONO-S ANASTOMOSIS FOR RESTORING BOWEL CONTINUITY AFTER ICR AT THE TEL AVIV MEDICAL CENTER FROM 11 JULY 2023 TO 3 APRIL 2025. 25 PATIENTS UNDERWENT ILEOCOLIC RESECTION WITH AN ANTIMESENTERIC FUNCTIONAL END-TO-END (KONO-S) ANASTOMOSIS. IN TOTAL, 10 PATIENTS (40%) HAD A STAPLED KONO-S ANASTOMOSIS AND 15 (60%) HAD A HANDSEWN KONO-S. THE HANDSEWN ANASTOMOSIS WAS DONE AS DESCRIBED IN PREVIOUS STUDIES [6], WHEREAS THE STAPLED KONO-S ANASTOMOSIS WAS D

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 24822272 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE MAIN BODY WAS BROKEN. 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 24793900 ↗