Echelon Linear Cutter GLC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705036030898), received between Dec 10, 2024 and Sep 15, 2026 — classified as 10 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (15 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Integrity Problem

  It was reported that during an Unknown procedure the GLC100 device was activated during the procedure. During the use of the third reload, a component detached from the device, resulting in device malfunction and preventing further use of the device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772111 ↗
• MalfunctionSep 14, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762649 ↗
• MalfunctionSep 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756116 ↗
• MalfunctionAug 4, 2026Failure to Fire

  It was reported that during an Unknown procedure unable to push GLC100 lever up to fire after multiple tries Was surgery delayed due to the reported event? Unknown, Was procedure successfully completed? Unknown, Were fragments generated? Unknown, If yes, were they removed easily without additional intervention? Unknown,Patient Status/ Outcome / consequences No, Was other medical intervention (e.g. X-rays, additional procedures, prescriptions, OTC, revision) required: Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131554 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE SURGEON REPORTED SCISSORING WHEN ATTEMPTING TO APPLY CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321561 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, THE SURGEON REPORTED SCISSORING WHEN ATTEMPTING TO APPLY CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321507 ↗
• MalfunctionMay 27, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRECTOMY, SURGEON FIRED THE GLC WITH GREEN RELOAD ON THE STOMACH AND SEVERAL STAPLES DID NOT FORM. IT LOOKS LIKE THEY DID NOT HIT THE ANVIL POCKETS. SURGEON WAITED 15 SECOND PRIOR TO FIRING AND SAID THE FORCE TO FIRE WAS NOT HIGHER THAN NORMAL. NO PATIENT CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS DELAYED BY 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302102 ↗
• MalfunctionMay 26, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER REPEATEDLY FAILED TO STITCH THE SUTURE, AND THE STAPLES WERE VISIBLY DEFORMED. THE SURGERY WAS DELAYED BY 10 MINUTES AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281011 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A MULTIPLE PROCEDURES DONE ON ONE PATIENT (ESOPHAGEAL RECONSTRUCTION, OPEN GASTRECTOMY, COLON CONDUIT, AND HERNIA REPAIR FEEDING TUBE), THE STAPLERS DID NOT FORM ON THE SECOND FIRING AND IT WAS FIRED ON LESSER CURVATURE OF THE STOMACH. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118323 ↗
• MalfunctionApr 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN RIGHT HEMICOLECTOMY, THE STAPLER FAILED TO CLOSE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980990 ↗
• MalfunctionApr 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER FIRING, THE STAPLE LINE IS OOZY AND SURGEON HAD TO SUTURE OVER THE STAPLE LINE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851939 ↗
• MalfunctionApr 3, 2026Failure to Form Staple; Unintended Compatibility

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE ECHELON LINEAR CUTTER 100 WITH A GREEN RELOAD FIRED ON THE ANASTOMOSIS AND HALF OF THE STAPLES HADN'T FORMED. I KNOW NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779780 ↗
• MalfunctionApr 1, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, THE ECHELON LINEAR CUTTER 100 WITH A GREEN RELOAD FIRED ON THE ANASTOMOSIS AND HALF OF THE STAPLES HADN'T FORMED. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753380 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED PARTIAL COLECTOMY. DOCTOR (B)(6) REALIZED TO COMPLETE ANASTOMOSIS. EXPERIENCED BLEEDING POSTOPERATIVELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24719825 ↗
• InjuryMar 3, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE LOW ANTERIOR RESECTION PROCEDURE WENT FINE BUT THE PATIENT HAD AN INFECTION AFTER THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24498535 ↗
• MalfunctionFeb 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY WITH BOWL RESECTION THAT THEY HAD TWO SUCCESSFUL FIRINGS, BUT WHEN THEY ATTEMPTED A THIRD FIRING THE STAPLER WOULDN'T CLOSE AND LOCK. THEY TRIED UNSUCCESSFULLY FOR ABOUT A MINUTE OR TWO AND DECIDED TO GET A NEW ONE. THEY THEN COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUES. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471901 ↗
• InjuryFeb 12, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD AN ISSUE WITH A COUPLE 80MM AND 100 MM STAPLERS. THE SURGICAL TECH SAID THE STAPLES WERE FALLING OUT OF THE TISSUE. 2 DIFFERENT 100 STAPLERS USED GREEN FOR STOMACH. LADY LOST A LOT MORE STOMACH THAN NEEDED HAD TO ULTIMATELY USE 80MM BLUE ACROSS THE STOMACH TWICE TO GET ADEQUATE APPOSITION AND CORRECTLY FIRE. STAPLE THRU THE TISSUE BUT NOT CURLED CLOSED. PROCEDURE IS DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: Bacterial Infection; Unspecified Tissue Injury

  MAUDE report 24326073 ↗
• InjuryFeb 12, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD AN ISSUE WITH A COUPLE 80MM AND 100 MM STAPLERS. THE SURGICAL TECH SAID THE STAPLES WERE FALLING OUT OF THE TISSUE. 2 DIFFERENT 100 STAPLERS USED GREEN FOR STOMACH. LADY LOST A LOT MORE STOMACH THAN NEEDED HAD TO ULTIMATELY USE 80MM BLUE ACROSS THE STOMACH TWICE TO GET ADEQUATE APPOSITION AND CORRECTLY FIRE. STAPLE THRU THE TISSUE BUT NOT CURLED CLOSED. PROCEDURE IS DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: Bacterial Infection; Unspecified Tissue Injury

  MAUDE report 24325999 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE A POST OPERATIVE LEAK FOLLOWING THE PROCEDURE USING THE GLC100 LINEAR STAPLER. PROCEDURE WAS COMPLETED WITH THE DEVICE AS NORMAL, HOWEVER THE SURGEON HAD POST OPERATIVE LEAKING WITH HIS PATIENTS. HE ATTRIBUTED THIS TO THE STAPLER AND HAS REVERTED TO OUR TLC STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 24239938 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN UNK PROCEDURE, THE SURGEON HAS REPORTED A POST OPERATIVE LEAK FOLLOWING THE PROCEDURE USING THE GLC100 LINEAR STAPLER. PROCEDURE WAS COMPLETED WITH THE DEVICE AS NORMAL, HOWEVER THE SURGEON HAD POST OPERATIVE LEAKING WITH HIS PATIENT. HE ATTRIBUTED THIS TO THE STAPLER AND HAS REVERTED TO OUR TLC STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 24167628 ↗
• InjuryJan 12, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ANASTOMOSIS THE DEVICE FAILED TO FIRE. HAD TO OPEN A SECOND DEVICE DURING SURGERY. ANASTOMOSIS FAILED, PATIENT HAD TO COME BACK FOR SECOND SURGERY AND WAS VERY UNWELL.

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

  MAUDE report 24045191 ↗
• MalfunctionJan 12, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE GLC STAPLE LINE WAS NOT FULLY CUT THROUGH - UNCLEAR IF THE DISTANCE BETWEEN STAPLE & CUT LINE IS THE INTENDED 9MM OR CAUSED BY AN INCOMPLETE KNIFE BLADE ADVANCEMENT. NO SIGNIFICANT RESISTANCE IN CLOSING AND FIRING OF STAPLER. CASE PROCEEDED WITH A SECOND RELOAD. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035701 ↗
• MalfunctionDec 31, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A ILEOPOUCH SURGERY, WHEN THE SURGEON PERFORMS THE HYDROPNEUMATIC TEST WITH BETADINE, THE SUTURE SHOWS FILTRATION OF LIQUID ALONG THE ENTIRE LENGTH OF THE SUTURE. THE PROCEDURE WAS DELAYED BY 15 MINUTES, MANUAL SUTURE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933686 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE PATIENT HAD AN INTRALUMINAL BLEEDING AFTER THE SURGERY. THE SURGEON HAD TO REOPERATE THE PATIENT THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23790098 ↗
• MalfunctionDec 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER WAS FIRED TWICE BEFORE THE ISSUE OCCURRED. ON THE THIRD FIRING, IT WAS NOTICED THAT THE STAPLES IN THE MIDDLE OF THE CARTRIDGE HADN'T FORMED A B SHAPE AND THE LEGS WERE UPRIGHT STICKING OUT OF THE TISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759133 ↗

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