ECHELON; ENDOPATH ECR45MRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705036001751), received between Jul 16, 2018 and Apr 23, 2025 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRE. 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 21894924 ↗
• MalfunctionMar 26, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE BASE WAS LOOSE. 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 21697018 ↗
• MalfunctionFeb 18, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY, IT WAS OBSERVED THAT THE STAPLE WAS NOT APPLIED PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402735 ↗
• MalfunctionApr 19, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE CARTRIDGE COULD NOT BE LOADED INTO THE DEVICE AT 1ST FIRING. THE DEVICE WAS USED ON THE BLOOD VESSELS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143656 ↗
• MalfunctionFeb 29, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS A GREY RELOAD WAS ATTEMPTED TO BE LOADED INTO AN EC3000 STAPLER. IT WOULD NOT FIT SO A NEW ONE WAS OPENED AND LOADED WITH NO PROBLEMS. THE RELOAD THAT DIDN¿T FIT WAS KEPT AND WILL BE SENT IN. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810970 ↗
• MalfunctionSep 12, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 17731390 ↗
• MalfunctionSep 12, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER THE DEVICE 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 17731324 ↗
• MalfunctionMay 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE THE SURGERY, NOTED THE DEVICE WAS DAMAGED AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020749 ↗
• MalfunctionMay 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE THE SURGERY, NOTED THE DEVICE WAS DAMAGED AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020707 ↗
• MalfunctionApr 7, 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 16703364 ↗
• MalfunctionFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY EMPLOYEE THAT DURING A PREFORMED SCANS, DOUBLE LOADED CARTRIDGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375210 ↗
• MalfunctionDec 20, 2021Failure 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 13043119 ↗
• MalfunctionJun 30, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING LEFT UPPER PNEUMONECTOMY SURGERY, WHEN SEVERING VASCULAR TISSUE, AFTER FIRED, NOTED SOME STAPLES MALFORMED. CHANGED TO 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 12097228 ↗
• MalfunctionJun 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ECR45M JAMMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965696 ↗
• MalfunctionMay 26, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 11886118 ↗
• MalfunctionApr 27, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY OF RIGHT LOWER LOBECTOMY, 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 11734943 ↗
• MalfunctionMar 2, 2021Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event; Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE VATS LEFT LOWER LOBECTOMY WITH EC45A+ ECR45W, THE FIRST FIRING WITH ECR45W WAS PERFORMED GOOD CUTTING LINE AND STAPLE LINE, THEN THE SECOND ECR45W WAS TRANSECTED THE BASAL SEGMENT OF THE LUNG, AFTER FIRED, THE STAPLES WAS MALFORMED WITH IRREGULAR SHAPES AND ONE STAPLE HOOKED THE VESSEL COULD NOT REMOVED THE INSTRUMENT, RESULTING IN TRACTION AND ARTERIAL WAS BLEEDING. FINALLY, THE STAPLES WERE REMOVED WITH THE ASSISTANCE OF OTHER DEVICES SUCH AS HEMOSTATIC FORCEPS, HEAD NURSE CLAIMED THAT JAW HAD FULLY CLEANED DURING THE RELOAD. NO ADDITIONAL COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400150 ↗
• MalfunctionFeb 3, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC NON-WEDGE RESECTION SURGERY, WHEN SEVERING RIGHT UPPER LOBE ARTERY TISSUE ON THE SECOND FIRING, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH SHAPE OF STRAIGHT LEG. 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 11276944 ↗
• MalfunctionAug 24, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING, SOME STAPLES FORMED WITH IRREGULAR SHAPES AND THE ANASTOMOTIC SITE WAS OOZING. ANOTHER TWO RELOADS HAD THE SAME ISSUE. OOZING WAS STOPPED WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443681 ↗
• MalfunctionAug 24, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING, SOME STAPLES FORMED WITH IRREGULAR SHAPES AND THE ANASTOMOTIC SITE WAS OOZING. ANOTHER TWO RELOADS HAD THE SAME ISSUE. OOZING WAS STOPPED WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443634 ↗
• MalfunctionAug 24, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING, SOME STAPLES FORMED WITH IRREGULAR SHAPES AND THE ANASTOMOTIC SITE WAS OOZING. ANOTHER TWO RELOADS HAD THE SAME ISSUE. OOZING WAS STOPPED WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443497 ↗
• MalfunctionAug 17, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC LOBECTOMY SURGERY, AFTER SEVERING PULMONARY LOBE TISSUE ON THE FIRST FIRING, ALL THE STAPLES WERE MALFORMED WITH STRAIGHT LEGS. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414709 ↗
• MalfunctionAug 17, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC LOBECTOMY SURGERY, AFTER SEVERING PULMONARY LOBE TISSUE ON THE FIRST FIRING, ALL THE STAPLES WERE MALFORMED WITH STRAIGHT LEGS. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414663 ↗
• InjuryApr 1, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOBECTOMY, NOT ALL STAPLES WERE PROPERLY FORMED. ABOUT HALF OF THE STAPLES WEREN'T PROPERLY B-SHAPED WHEN FIRING OVER THE ARTERIA PULMONALIS. THE SURGEON HAD TO EXECUTE A THORACOTOMY TO COMPLETE THE PROCEDURE. IT'S UNKNOWN WHETHER THERE WERE ANY PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 9909832 ↗
• MalfunctionNov 7, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LOBECTOMY 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 Consequences Or Impact To Patient

  MAUDE report 9293161 ↗