ECHELON GCR40GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036027478), received between Apr 21, 2023 and Jun 9, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER MISSED FIRED. IT HAPPENED TWICE 4/27 AND LAST WEEK. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445764 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, ECHELON CONTOUR CURVED CUTTER MISFIRED - THIS CAUSED SURGEONS TO HAVE TO CHANGE SURGICAL PLAN FROM RE-JOINING BOWEL TO STOMA FORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24096818 ↗
• MalfunctionOct 15, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING THE ANTERIOR RECTAL RESECTION SURGERY WITH DR., CONTOUR WAS USED FOLLOWING ALL THE CORRESPONDING INDICATIONS FOR USE. THE DEVICE WORKED SUCCESSFULLY ON THE FIRST SHOT. HOWEVER, WHEN MAKING THE SECOND SHOT, A NEW RELOAD WAS REQUESTED, WHICH WAS MOUNTED ON THE CONTOUR PROPERLY. WHEN SHOOTING WITH THE REFILL, THERE WERE FAILURES IN THE FORMATION OF THE STAPLE LINE AND IN THE TISSUE SECTION, SO IT WAS NECESSARY TO MAKE AN ADDITIONAL SHOT WITH ECHELON PLUS. THE SURGERY WAS DELAYED 15 MINUTES. COMPLETE RESECTION WITH ECHELON PLUS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288920 ↗
• MalfunctionSep 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD FOR THE CONTOUR STAPLER DID NOT EJECT THE STAPLES WHEN FIRED. THIS INCIDENT DID NOT AFFECT THE PATIENT'S OUTCOME; A NEW REFILL WAS USED ON THE SAME STAPLER. THE DURATION OF THE OPERATION WAS EXTENDED, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072214 ↗
• MalfunctionJan 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THE DEVICE WAS CLOSED ON TISSUE, FIRE THE STAPLER PROPERLY AND ALSO GOT AUDIBLE FEEDBACK. AFTER HE OPENED THE STAPLER HE SAW THAT COLON IS TRANSECTED BUT THERE WERE NO STAPLERS, SO STAPLER DID ONLY TRANSECTION WITHOUT CLAMPS IN IT. WE PUT A RELOAD ASIDE AND IT WILL BE SEND FOR INSPECTION. THE SURGERY WAS DELAYED 20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055977 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON FIRED THE PRODUCT, DIDN'T NOTICE PATIENT ISSUES DURING THE CASE BUT 7-9 DAYS AFTER THE PATIENT HAD BECAME SEPTIC AND WHEN THEY CAME IN TO RE-OPERATE THEY NOTICED THE STAPLE LINE WAS OPEN SHOWING LEAKS. THEY USED A NEW STAPLER AND REINFORCED IT WITH SUTURES TO SEAL/PREVENT THE LEAKAGE. STAPLE LINE WAS VISUALIZED DURING THE INITIAL SURGERY FOR PATIENT AND APPEARED NORMAL AND THERE WERE NO ISSUES EXPERIENCED WITH THE DEVICE DURING THE INITIAL SURGERY.

  Patient problems: Abdominal Distention; Failure to Anastomose; Sepsis

  MAUDE report 19297768 ↗
• MalfunctionApr 21, 2023Difficult to Insert; Difficult to Open or Close; Difficult to Insert; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD SEEMED TO BE DEFECTIVE. WHEN I PICKED UP THE STAPLER, THE CLOSING HANDLE WOULDN'T CLOSE. I PUSHED THE RELOAD IN FURTHER AND CLOSING HANDLE CLOSED AND SEEMED TO BE OK. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790975 ↗