ECHELON Flex ENDOPATH PLE45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705036014379), received between Dec 11, 2017 and Jan 16, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER JAMMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100922 ↗
• MalfunctionFeb 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, IT WAS OBSERVED THAT THE STAPLER STOPPED WORKING, APPARENTLY DUE TO BATTERY PROBLEMS AND DAMAGING A BLUE CHARGE AT THE TIME OF SHOOTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375638 ↗
• MalfunctionSep 24, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER LOCKED AT THE LAST SHOT, AFTER INTESTINAL STAPLING WITH THE WHITE RELOAD. SINCE IT WAS PRECISELY THE LAST SHOT, IT WAS NOT NECESSARY TO REPLACE IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291986 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem; Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT THE PRESENT STAPLER PRESENTED DIFFICULTIES IN HANDLING FROM THE BEGINNING, WHEN REPLACING THE LOAD, A SMALL SPRING CAME OUT. VERY SOFT IN THE JOINT AND LOCKING WHEN OPENING THE JAW. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142926 ↗
• MalfunctionApr 9, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING GASTRIC SECTION THE STAPLER STOPPED AFTER FINISHING THE THIRD STAPLING WITH A GREEN LOAD, REQUIRING MANUAL OPENING WITH SUBSEQUENT REPLACEMENT BY A NEW STAPLER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075999 ↗
• MalfunctionFeb 2, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE FIRST STAPLING, IN THE MAKING OF THE Y, THERE WAS A FAILURE IN THE STAPLER, WITHOUT TRIGGERING IT. EVIDENCED A YELLOW LOOSE PART NEAR THE SAFETY LOCK. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631149 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LAST NIGHT WE RECEIVED A COMPLAINT FROM THE DOCTOR THAT HE HAD PROBLEMS IN THE POSTOPERATIVE PERIOD WHO UNDERWENT THE PROCEDURE. THE PATIENT HAD POST-SURGICAL ENTERORRHAGIA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15469839 ↗
• MalfunctionMay 12, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THAT THE ECHELON POWER STAPLER HAD A DAMAGED LOAD TRIGGER AND BROKE DURING SURGERY IN ITS FIRST HANDLING. REPLACEMENT OF ANOTHER STAPLER WAS NECESSARY FOR THE CONTINUATION OF THE OPERATION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14373993 ↗
• MalfunctionAug 26, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING STAPLING, OPENED ROWS OF STAPLES IN THE FIRST STAPLING OF THE POUCH. NO HARM TO THE PATIENT, THE DOCTOR REINFORCED THE STAPLE LINE WITH SUTURE. THE MANUAL METHOD WAS USED TO REINFORCE THE STAPLE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374845 ↗
• MalfunctionMay 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: ¿RECEIVED 1BX OF ETHPLE45A LABELED WITH A DIFFERENT LOT NUMBER AND EXPIRATION DATE THAN WHAT WAS ACTUALLY IN THE BOX. ITEM ETHPLE45A WAS RECEIVED WITH THE OUTER CARTON STICKER LOT # T9468Y, EXP-2022-07-31 BUT THE ACTUAL MEDLINE: (B)(4) ETHPLE45A- (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897821 ↗
• MalfunctionMay 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: ¿RECEIVED 1BX OF ETHPLE45A LABELED WITH A DIFFERENT LOT NUMBER AND EXPIRATION DATE THAN WHAT WAS ACTUALLY IN THE BOX. ITEM ETHPLE45A WAS RECEIVED WITH THE OUTER CARTON STICKER LOT # T9468Y, EXP-2022-07-31 BUT THE ACTUAL MEDLINE: 200434745 -ETHPLE45A - (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897776 ↗
• MalfunctionApr 21, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: ¿RECEIVED 1BX OF ETHPLE45A LABELED WITH A DIFFERENT LOT NUMBER AND EXPIRATION DATE THAN WHAT WAS ACTUALLY IN THE BOX. ITEM ETHPLE45A WAS RECEIVED WITH THE OUTER CARTON STICKER LOT# T9468Y, EXP-2022-07-31, BUT THE ACTUAL MEDLINE: 200434745--ETHPLE45A--4509653161.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703812 ↗
• MalfunctionMar 30, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THERE WAS A FAILURE TO STAPLE THE FIRST RELOAD DURING THE PREPARATION OF THE GASTRIC POUCH WITH INCOMPLETE CLOSURE OF THE STAPLE LINES (DID NOT STAPLE THE EXCLUDED STOMACH SIDE AND COMPLETE STAPLES ON THE GASTRIC POUCH SIDE). TOTAL FLAT SUTURE OF THE EXCLUDED STOMACH AND ANOTHER SUTURE IN THE SEROMUSCULAR PLANE WERE PERFORMED, BOTH WITH 3-0 PDS. OPTED TO REPLACE THE STAPLER FOR THE SEQUENCE OF THE SURGERY. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590646 ↗
• InjuryFeb 6, 2020Failure to Form Staple

  IT WAS REPORTED THAT THERE WAS MORE INTENSE THAN NORMAL BLEEDING FROM THE STAPLE LINE, AND REALIZE THAT THE TISSUE IS NOT BEING CUT BY THE BLADE AS IT NORMALLY DID. SURGEON REPORTED THAT DURING THE GASTROPLASTY PROCEDURE THERE WAS BLEEDING IN THE STAPLE LINE, REQUIRING THE USE OF CLIPS AND ITS REPLACEMENT. THE TECHNIQUE WAS BYPASS. ON THE FIRST POSTOPERATIVE DAY THE PATIENT CONTINUED TO BLEED AND HIS HEMOGLOBIN DROPPED TO 7. THE PATIENT WAS UNDER OBSERVATION FOR ANOTHER 2 DAYS IN THE HOSPITAL, PROGRESSED WELL AND WAS DISCHARGED.

  Patient problems: Blood Loss; Not Applicable

  MAUDE report 9676175 ↗
• InjuryJan 17, 2020Leak/Splash

  IT WAS REPORTED THAT ON THE 2ND POSTOPERATIVE DAY, THE PATIENT WAS TACHYCARDIC, HAD AN IMAGING EXAM, THE SAME WAS NOT CONCLUSIVE AND RESOLVED TO REINTERVENTION THE PATIENT. WHEN HE ENTERED THE CAVITY, HE NOTICED THAT THERE WAS A LEAK IN HIS STOMACH, CONCLUDING THAT THERE WAS A FISTULA BETWEEN THE 2ND AND 3RD STAPLED GREEN CHARGE AND GOLDEN CHARGE. THE TECHNIQUE WAS SLEEVE. HE PLACED A DRAIN ON THE PATIENT AND WILL FOLLOW THE ENDOSCOPIC TREATMENT.

  Patient problems: Failure to Anastomose; Fistula; No Code Available

  MAUDE report 9601226 ↗
• MalfunctionDec 7, 2018Mechanical Problem

  IT WAS REPORTED THAT THE ECHELON POWER 45 STAPLER (PLE45A) USED FOR BARIATRIC PROCEDURE, AFTER THE 4TH FIRING, IT NO LONGER ALLOWED TO FIT THE ANOTHER LOAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141699 ↗
• InjuryNov 29, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ON THE THIRD SHOT OF THE BLUE ECR45B RELOAD IN THE STOMACH, THE STAPLER DID NOT PROPERLY FORM THE STAPLE LINE, AND PART OF THE STAPLE LINE OPENED. IT WAS PERFORMED A NEW STAPLING ATTEMPT WITH THE SAME STAPLER AND THE TRIGGER WAS NOT PERFORMED. THE STAPLER HAD TO BE REPLACED DURING THE PROCEDURE. IT WAS REPORTED THAT IN THE POST PROCEDURE THE PATIENT PRESENTED FISTULA IN THE PART WHERE THE STAPLE LINE WAS MALFORMED.

  Patient problems: Fistula; No Code Available

  MAUDE report 8115094 ↗
• MalfunctionSep 14, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, ON THE FIRST STAPLING THE DEVICE DID NOT TRIGGER ALL THE STAPLES OF THE RELOAD AND DID NOT FORM THE STAPLE LINE PROPERLY. THEY USED A NEW RELOAD AND IT DID NOT STAPLE. A NEW STAPLER WAS REQUESTED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877367 ↗
• MalfunctionAug 23, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING GASTROPLASTY, THE STAPLER PRESENTED LOCKING OF ITS BLADE (DID NOT BACK OFF) AFTER THE FIRST SHOT AND DID NOT RECOIL (BACK OFF) EVEN AFTER THE REVERSE WAS TRIGGERED. IT WAS USED A SECOND STAPLER (RESERVE) FOR COMPLETION OF SURGERY; THIS ONE WORKED WITHOUT INTERCURRENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809653 ↗
• MalfunctionJul 18, 2018Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE PROCEDURE (VIDEO GASTROPLASTY), THERE WAS A PROBLEM WITH THE STAPLER. IN THE LAST ANASTOMOSIS, IT PRESENTED A DEFECT. THE ROUTINE PROCEDURE WAS DONE, THE REVERSE WAS DONE, BUT THE DEVICE DID NOT SHOOT ANY MORE STAPLES, AND DID NOT OPEN. IT WAS REQUESTED A NEW MATERIAL: 01 STAPLER AND 01 RELOAD. THE PATIENT HAD NO SERIOUS ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699991 ↗
• MalfunctionDec 13, 2017Failure to Fire

  IT WAS REPORTED THAT THE STAPLER PRESENTED LOCKING IN THE 4TH SHOT WITH GOLD RELOAD. IT WAS PERFORMED MANEUVERS GUIDED BY OPERATING COMPANY, WITHOUT EFFECT. IT WAS NECESSARY TO REPLACE IT TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7114065 ↗
• MalfunctionDec 11, 2017Mechanical Problem

  DURING LAPAROSCOPIC PLACEMENT OF PERITONEAL DIALYSIS CATHETER, LINEAR CUTTER WOULD NOT ENGAGE WHEN THE SURGEON ATTEMPTED TO USE THE DEVICE. NEW DEVICE WAS USED WITHOUT ANY ISSUES. NO PATIENT HARM. DEVICE TO BE RETURNED TO MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7103835 ↗