ECHELON; ENDOPATH ECR45GRecalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10705036001744), received between Jun 19, 2018 and Aug 14, 2026 — classified as 3 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (68 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258717 ↗
• MalfunctionApr 11, 2026Failure 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 24847360 ↗
• MalfunctionJan 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN 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 24177492 ↗
• 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 23803695 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 23546739 ↗
• MalfunctionOct 15, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THEY OPENED THE PACKING AND NOTED THAT SOME STAPLES FELL OFF. CHANGED TO A 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 23290592 ↗
• MalfunctionJun 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. 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 22144488 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POST-OPERATIVE COURSE FOLLOWING AN OPEN LOBECTOMY IN WHICH THE FISSURE HAD BEEN COMPLETED WITH ECHELON 3000 AND BLUE RELOADS THE PATIENT HAD AN AIR LEAK. LONG HOSPITAL STAY.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 21953420 ↗
• InjuryMay 1, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE AFTERNOON OF THE SECOND DAY AFTER SURGERY, THE PATIENT COMPLAINED OF BUBBLE OVERFLOW IN WATER-SEALED BOTTLE WHEN COUGHING, WHICH WAS CONSIDERED TO BE LUNG WOUND LEAKAGE, AND THE AIR LEAKAGE WAS AGGRAVATED GRADUALLY, WHICH WAS CONSIDERED TO BE POOR NAILING OF OCCLUDER. THE SYMPTOMS WERE IMPROVED AFTER INTRATHORACIC INFUSION OF HIGH GLUCOSE, AND THERE WAS STILL A SMALL AMOUNT OF AIR LEAKAGE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 21945997 ↗
• MalfunctionMay 1, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT AFTER FIRING THE DEVICE, THE STAPLES WERE 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 21945187 ↗
• MalfunctionApr 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE 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 21868200 ↗
• MalfunctionMar 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN 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 21505281 ↗
• MalfunctionMar 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN 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 21505144 ↗
• MalfunctionFeb 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY 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 21346469 ↗
• MalfunctionJan 27, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY PROCEDURE, IT WAS OBSERVED THAT SOME STAPLES MALFORMED AND OOZING OCCURRED AFTER FIRED. SUTURE WAS USED TO OVERSEW. 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 21241821 ↗
• MalfunctionJan 22, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A WEDGE RESECTION 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 21208603 ↗
• MalfunctionJan 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A 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 21197638 ↗
• MalfunctionJan 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PANCREAS PROCEDURE 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 21197497 ↗
• MalfunctionDec 30, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037381 ↗
• MalfunctionNov 8, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, NOTED THAT SOME SLED FELL OFF. 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 20643030 ↗
• MalfunctionNov 6, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, NOTED THE CARTRIDGE PAN SEPARATION. 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 20622608 ↗
• MalfunctionOct 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395982 ↗
• MalfunctionSep 26, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LUNG RESECTION 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 20312427 ↗
• MalfunctionSep 6, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RECTUM PROCEDURE, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156029 ↗
• MalfunctionSep 6, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RECTUM PROCEDURE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156003 ↗