ECHELON ENDOPATH EC45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 753 adverse event reports that list this exact device (DI 10705036001676), received between Jan 20, 2015 and Sep 30, 2026 — classified as 9 deaths, 79 injuries, 665 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (304 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 753 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Difficult to Open or Close

  Patient problems: Insufficient Information

  MAUDE report 50948133 ↗
• MalfunctionSep 28, 2026Failure to Fire

  It was reported that during an unspecified surgical 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 50921116 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915789 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close

  It was reported that the EC45A was removed from the Appendix Kit and prepared according to the standard procedure. The reload was then inserted and the surgeon took the stapler, closed it, and inserted it through the trocar. After insertion, the surgeon was no longer able to open the stapler. As a result, the device could not be used. There were no adverse consequences reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803215 ↗
• MalfunctionAug 26, 2026Difficult to Open or Close

  It was reported that during an unspecified surgical procedure, it was observed that after 7 successful firings the 45mm Echelon with GST45G refused to return the knife automatically. Therefore they used the reverse knife button. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459044 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254295 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254245 ↗
• MalfunctionAug 10, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194880 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 25612778 ↗
• MalfunctionJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN APPENDIX REMOVAL, THE STAPLER CLOSED ON THE TISSUE BUT DID NOT FIRE CORRECTLY. THE SURGEON WAS ABLE TO DISENGAGE THE STAPLER WITH NO DAMAGE. THE SURGEON USED POWER DEVICE INSTEAD 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 25579799 ↗
• MalfunctionJun 17, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537799 ↗
• MalfunctionJun 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 25537198 ↗
• MalfunctionJun 17, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT AFTER FIRING 5 CARTRIDGES WITH ECHELON FLEX 45 EC45A (MANUAL STAPLER), THEY LOADED THE 6TH ONE (GST45B) AND INTRODUCED IT ON THE TROCAR. THE HANDLE BLOCKED IN CLOSED POSITION, COULD NOT BE OPENED ANYMORE ONCE IN ABDOMINAL CAVITY. NO TISSUE WAS CAUGHT WITHIN THE JAWS OF STAPLER. SURGERY WAS COMPLETED USING NEW INSTRUMENT ECHELON FLEX 45 AND NEW CARTRIDGE WITH A DELAY OF 30 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534374 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 25445469 ↗
• MalfunctionJun 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 25414509 ↗
• MalfunctionJun 3, 2026

  THE ETHICON ARTICULATING ENDOSCOPIC LINEAR CUTTER (REF EC45A) WOULD NOT FIRE A STAPLE LOAD DURING THE PROCEDURE AND THERE WAS SOME DIFFICULTLY REOPENING THE STAPLER TO REMOVE FROM THE PATIENT. AFTER REMOVAL, THIS WAS ATTEMPTED WITH A SECOND STAPLER (SAME PRODUCT, SAME LOT NUMBER - 694D40). THE SAME ISSUE OCCURRED WITH THE SECOND STAPLER. MANUFACTURER RESPONSE FOR STAPLE, IMPLANTABLE, ECHELON ENDOPATH (PER SITE REPORTER). UNKNOWN; ALL DEVICES WITH SAME LOT NUMBER WERE TAKEN BY ETHICON REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374218 ↗
• MalfunctionMay 14, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE MALFUNCTIONED. THE PROCEDURE WAS DELAYED BY 45 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175704 ↗
• MalfunctionMay 14, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS UNABLE TO CUT EFFECTIVELY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171783 ↗
• MalfunctionMay 13, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER JAMMED. TWO CARTRIDGES WERE FIRED, AND THE THIRD JAMMED; THE JAWS DID NOT FUNCTION PROPERLY. THE DEVICE WAS REMOVED FROM THE ABDOMEN AND TESTED ON PAPER, BUT THE CUTTING FUNCTION DID NOT WORK. A NEW STAPLER HAD TO BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160650 ↗
• MalfunctionMay 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT NO FUNCTION OCCURRED AT THE TIP OF THE DEVICE WHEN TRIGGER MECHANISM WAS ACTUATED. 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 25069500 ↗
• MalfunctionApr 29, 2026Failure to Form Staple; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LOBECTOMY SURGERY, AFTER FIRED, COULD NOT OPEN THE JAW. USED RBRB TO OPEN THE JAW AND REMOVED THE DEVICE, AND THEN 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 25028715 ↗
• MalfunctionApr 27, 2026Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS UNABLE TO CUT EFFECTIVELY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000384 ↗
• MalfunctionApr 14, 2026Mechanical Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BECAME STUCK IN THE TISSUE AFTER FIRING. THE RED EMERGENCY RELEASE BUTTON DID NOT WORK. THE TISSUE HAD TO BE RELEASED USING ANOTHER STAPLER. THE PROCEDURE WAS PROLONGED BY AN UNKNOWN AMOUNT OF TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876020 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A BYPASS GASTROPLASTY ON (B)(6) 2026, AFTER 36 HOURS OF IPO HE WAS REFERRED TO THE ICU WITH HEMORRHAGIC SHOCK, TESTS WERE DONE AND BLEEDING FROM THE STAPLE LINE OF THE ENTERO ANASTOMOSIS WAS FOUND. THE PATIENT REMAINED IN THE ICU FOR 3 DAYS, WITH REVERSAL OF THE SHOCK WITH TREATMENT WITH MEDICATIONS AND 5 BAGS OF BLOOD, HOWEVER, THE DOCTOR INFORMED ABOUT THIS EVENT ONLY ON (B)(6) 2026, AND THE MATERIAL USED WAS NOT STORED FOR EVALUATION. WAS THERE ANY DAMAGE OR LOSS REPORTED BY THE PATIENT OR USER? YES. DID THE PATIENT/USER REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT? YES. DESCRIPTION: ICU ADMISSION, BLOOD BAGS. INCREASE IN HOSPITALIZATION DAYS. DID THE PATIENT/USER REQUIRE PROLONGED HOSPITALIZATION AS A RESULT OF THE EVENT? YES. DESCRIPTION: TREATMENT FOR HEMORRHAGIC SHOCK. WHAT IS THE PATIENT/USER STATUS/OUTCOME AFTER THE EVENT? WAS DISCHARGED HOME AFTER 5 DAYS OF HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24764794 ↗
• MalfunctionMar 31, 2026Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WAS STUCK ON THE CYSTIC DUCT/CYSTIC ARTERY DURING THE FIRING PROCESS. STAPLER WAS STUCK AND LOCKED OUT. STAFF FOLLOWING LOCKOUT PROTOCOL AND SPECIFIC TROUBLESHOOTING STEPS. NOTHING WAS WORKING, SO SURGEON HAD TO CLIP AND CUT TO MAINTAIN STABILITY OF ARTERY. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24745214 ↗