ECHELON; ENDOPATH ECR45WRecalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10705036001768), received between Dec 1, 2017 and Mar 23, 2026 — classified as 13 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (69 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Separation Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO A LAPAROSCOPIC LOBECTOMY, IT WAS OBSERVED THAT THERE WAS CARTRIDGE PAN SEPARATION IN THE PACKAGING OF THE DEVICES. THERE WERE FOUR DEVICES WITH THE SAME ISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663823 ↗
• MalfunctionMar 23, 2026Separation Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO A LAPAROSCOPIC LOBECTOMY, IT WAS OBSERVED THAT THERE WAS CARTRIDGE PAN SEPARATION IN THE PACKAGING OF THE DEVICES. THERE WERE FOUR DEVICES WITH THE SAME ISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663806 ↗
• MalfunctionMar 23, 2026Separation Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO A LAPAROSCOPIC LOBECTOMY, IT WAS OBSERVED THAT THERE WAS CARTRIDGE PAN SEPARATION IN THE PACKAGING OF THE DEVICES. THERE WERE FOUR DEVICES WITH THE SAME ISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663803 ↗
• MalfunctionJan 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23977241 ↗
• MalfunctionJan 2, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE CLOSED STAPLES UNRAVELED WHEN VESSEL WAS CLOSED INTRAOPERATIVELY. 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 23949789 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23804492 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23804440 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23803621 ↗
• MalfunctionNov 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23466396 ↗
• MalfunctionOct 30, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE TISSUE WAS NOT COMPLETELY CLOSED DUE TO THE FAULTY B FORMATION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426421 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A LAPAROSCOPIC LOBECTOMY THORACIC PROCEDURE, BLEEDING ON THE SECOND POSTOPERATIVE DAY. EMERGENCY THORACOSCOPIC EXPLORATION, THORACIC BLOOD CLOT DEBRIDEMENT, HEMOSTASIS. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23403911 ↗
• MalfunctionOct 27, 2025Failure to Form Staple; Material Integrity Problem; No Apparent Adverse Event; Failure to Form Staple; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LOBECTOMY, IT WAS OBSERVED THAT THE CARTRIDGE HAD A BULGE IN THE MIDDLE PORTION; AND THERE WAS BLEEDING FROM THE CARTRIDGE FACE. THE PHYSICIAN IMMEDIATELY STOPPED THE BLEEDING WITH A VASCULAR CLIP. THERE WAS AN UNSPECIFIED INCREASED IN THE PROCEDURE TIME. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 23393019 ↗
• MalfunctionSep 5, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 22980115 ↗
• MalfunctionAug 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 22815133 ↗
• MalfunctionJul 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. THEY CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 22471017 ↗
• MalfunctionJul 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. THEY CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 22471014 ↗
• MalfunctionJul 10, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS USED TO DISCONNECT THE LEFT INFERIOR PULMONARY VEIN. AFTER DISCONNECTING THE LEFT INFERIOR PULMONARY VEIN, IT WAS FOUND THAT THE NAIL EDGE AT THE DISTAL END OF THE VEIN WAS NOT FULLY CLOSED, RESULTING IN BLEEDING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 22470941 ↗
• MalfunctionDec 30, 2024Failure to Form Staple; Failure to Form Staple

  THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. SUTURE WAS USED TO OVERSEW. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036946 ↗
• MalfunctionNov 7, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, COULD NOT FIRE FARTHER AFTER FIRED A LITTLE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632730 ↗
• InjurySep 18, 2024Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LEFT UPPER LOBECTOMY, AFTER A FIRE, NOTED THE STAPLES ONLY DEPLOYED ON ONE SIDE OF THE RELOAD, WHICH CAUSED MASSIVE BLEEDING. CHANGED TO OPEN OPERATION TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED FOR ABOUT 1 HOUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20250793 ↗
• MalfunctionJun 26, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615093 ↗
• MalfunctionJun 25, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING PROCEDURE, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606459 ↗
• MalfunctionJun 24, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593870 ↗
• MalfunctionMay 8, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE RELOAD WAS USED WITH THE STAPLER, BUT AS THE SCRUB NURSE TRIED TO LOAD THE RELOAD, THE BLUE PLASTIC PIECE AT POSTERIOR END OF RELOAD, FELL OUT. SHE SUBSEQUENTLY ASKED FOR A NEW RELOAD TO BE OPENED AS SHE WAS NOT COMFORTABLE PUSHING BACK THE LITTLE BLUE PIECE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272086 ↗
• MalfunctionMay 3, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242474 ↗