ECHELON; ENDOPATH ECR45DRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 10705036001737), received between Dec 19, 2017 and Dec 15, 2025 — classified as 115 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (87 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 115 reports, in the reporter's own words as published by the FDA.

• 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 23804413 ↗
• 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 23804366 ↗
• 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 23804287 ↗
• 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 23803722 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE WAS DAMAGED. CHANGED TO NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687405 ↗
• 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 22980116 ↗
• MalfunctionAug 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 22819770 ↗
• MalfunctionMay 7, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE RELOAD USED DID NOT TRIGGER WHEN STAPLING. 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 21977547 ↗
• MalfunctionJan 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRE FARTHER AFTER FIRED A HALF. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241948 ↗
• MalfunctionDec 30, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES 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 21036907 ↗
• MalfunctionSep 12, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LOBECTOMY SURGERY, 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 20201608 ↗
• MalfunctionMay 14, 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 19315235 ↗
• MalfunctionApr 30, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE PACKAGE AND NOTED THE METAL PART OF CARTRIDGE WAS DEFORMED. 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 19213443 ↗
• MalfunctionFeb 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, DEVICE 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 18676245 ↗
• MalfunctionNov 30, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING THE UNK SURGERY, NOTED THAT CARTRIDGE BASE LOOSE AND COULD NOT INSTALL. 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 18237489 ↗
• MalfunctionNov 27, 2023Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE  SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED   AND OOZING OCCURRED. CHANGED THE NEW RELOAD TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

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

  MAUDE report 18210446 ↗
• MalfunctionAug 14, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 17546082 ↗
• MalfunctionJul 13, 2023Failure 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 17321416 ↗
• MalfunctionJul 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE CARTRIDGE DAMAGED. 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 17306183 ↗
• MalfunctionJul 11, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY , 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 17298661 ↗
• MalfunctionJun 20, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 17162648 ↗
• MalfunctionJun 16, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY , 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 17143014 ↗
• MalfunctionJun 15, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED  AND OOZING OCCURRED. TO STOP OOZING WITH HEMOSTATIC MATERIALS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137908 ↗
• MalfunctionMay 26, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, 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 17010478 ↗
• MalfunctionMay 12, 2023Failure to Form Staple; Failure to Form Staple

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922522 ↗