ECHELON ENDOPATH EC45ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705036001683), received between May 7, 2018 and Nov 12, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE OPENED AFTER INSERTION THROUGH THE TROCAR. ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535122 ↗
• MalfunctionJul 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE JAW ON THE DEVICE WAS TWISTED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613284 ↗
• MalfunctionJul 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER CUT OFF A PART BUT DID NOT REACH THE END. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612541 ↗
• MalfunctionOct 14, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ECHELON GUN DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446114 ↗
• InjuryAug 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A GASTRIC BYPASS PROCEDURE, ONE DAY POST-OPERATIVELY (DPO) OF THE PROCEDURE, IT WAS OBSERVED THAT A FISTULA OCCURRED IN THE STAPLE LINE OF THE GASTROENTERO-ANASTOMOSIS. THE PATIENT WAS REASSESSED AND IS CURRENTLY STABLE. NO FURTHER SURGICAL INTERVENTION HAS BEEN CARRIED OUT.

  Patient problems: Fistula

  MAUDE report 19981429 ↗
• MalfunctionNov 18, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE THE DEVICE WOULD NOT FIRE AND LOCKED OUT. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828227 ↗
• MalfunctionSep 24, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE ECHELON ENDO STAPLER STUCK WITH THE LOAD, REQUIRING A STAPLER REPLACEMENT. DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478977 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EVOLVED WITH IMPORTANT DIGESTIVE HEMORRHAGE. READMITTED FOR EVALUATION, REQUIRING BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15429526 ↗
• MalfunctionJul 14, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING GASTROENTEROANASTOMOSIS, THE STAPLING WAS 1CM. SURGEON HAD TO PERFORM MANUAL ANASTOMOSIS. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018559 ↗
• InjuryMar 25, 2022Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON TRIED TO USE MULTIPLE STAPLES ACROSS VERY CALCIFIED TISSUE. HE WAS UNABLE TO CLOSE THE DEVICE. AFTER SEVERAL ATTEMPTS THIS STAPLER WAS ABLE TO CLOSE ON VESSEL. THE PATIENT BEGAN TO BLEED AND SEVERAL UNITS OF BLOOD WERE USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13901943 ↗
• MalfunctionNov 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, SURGEON FIRED ONE WHITE LOAD SUCCESSFULLY, CLOSED JAWS TO REMOVE STAPLER FROM PATIENT, SCRUB COULD NOT GET JAWS OPEN TO RELOAD STAPLER. REPLACED WITH NEW EC45A AND CONTINUED CASE NORMALLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10784909 ↗
• MalfunctionSep 21, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DURING A GASTRIC BYPASS SURGERY, AFTER TRIGGERING A MAGAZINE, THE STAPLE SUTURE ROW LOOKED LIKE IT HAD BEEN BROKEN OFF. THE STAPLER WAS THEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10562318 ↗
• MalfunctionFeb 21, 2020Break

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE LOCKING LEVER BROKE OFF WHEN TRIGGERED. AFTER THAT, THE DEVICE COULD NO LONGER BE OPENED. THE INSTRUMENT HAS TO BE CUT OUT WITH A SECOND ECHELON DEVICE. THE SURGERY TIME WAS EXTENDED ABOUT 45 MIN, BECAUSE ANOTHER ANASTOMOSIS (SMALL INTESTINE-SMALL INTESTINE) HAD TO BE DONE. NO PIECES FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9738716 ↗
• MalfunctionJul 1, 2019Mechanical Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE STAPLER LOCKED AND THEN IT WOULDN'T UNLOCK. THE LOAD LOCKED AND WOULDN¿T UNLOCK DURING THE TEST BEFORE USING THE DEVICE. THE DEVICE NOT STUCK ON TISSUE WITH THE JAWS CLOSED. THE RED MANUAL KNIFE REVERSE SWITCH WAS ATTEMPTED BUT IT DID NOT FUNCTION AS DESIGNED AND WAS STUCK. "THE JAWS OF THE DEVICE DID NOT OPEN, THEY CHANGED THE CASSETTE." THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750950 ↗
• MalfunctionMay 1, 2019Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, AFTER FIRING WHEN TRYING TO OPEN THE GUN IT WAS STUCK IN THE TISSUE AND WAS NOT OPENING. PUSHED THE CLOSING TRIGGER FROM OUTSIDE AND OPEN THE JAW. FOUND THE DEFECT IN THE FIRST CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568545 ↗
• MalfunctionMar 8, 2019Mechanical Jam

  IT WAS REPORTED THAT DURING A ROBOTIC PROSTATECTOMY, WHILE TAKING THE DORSAL VENUS COMPLEX, THE STAPLER, WITH WHITE RELOAD, NO BUTTRESSING MATERIAL, LOCKED ON TISSUE. THE STAPLER WAS REMOVED FROM TISSUE BY USING THE ROBOT ARM TO SEPARATE THE JAWS. THE PROCEDURE WAS COMPLETED USING SUTURE. THERE WAS POSSIBLE INJURY TO THE URETER BUT NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405617 ↗
• MalfunctionMay 7, 2018Mechanical Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, A FEW MONTHS AGO THAT THE DEVICE CLOSED ON TISSUE, STAPLED AND CUT, BUT WOULD NOT UNLOCK. THE SURGEON WIGGLED THE DEVICE UNTIL IT REMOVED FROM TISSUE. AT THIS POINT THEY WERE FINISHED WITH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490621 ↗