ENDOPATH TR45WRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705036003182), received between Feb 2, 2018 and Feb 5, 2026 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (23 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ESOPHAGEAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE COMPLETELY WHEN USED FOR AN ESOPHAGEAL POUCH BUT FUNCTIONED NORMALLY WHEN TESTED AFTERWARDS. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267982 ↗
• MalfunctionFeb 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER MISFIRED AND THE STAPLE LINE WAS NOT COMPLETED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306928 ↗
• MalfunctionOct 14, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER SETTING, STAPLE WAS REPLACED BECAUSE IT WAS PROTRUDING. 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 20438455 ↗
• MalfunctionOct 14, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER SETTING, STAPLE WAS REPLACED BECAUSE IT WAS PROTRUDING. 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 20438436 ↗
• MalfunctionJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625056 ↗
• MalfunctionApr 3, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CARTRIDGE CANNOT BE COMFORTABLY SITTED ON THE JAW OF THE STAPLER. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035714 ↗
• MalfunctionMar 1, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; WHILE USING AN ATS 45 STAPLER WITH A ENDO LINEAR CUTTERS RELOAD TO STAPLE THE LUNG. THE STAPLER FIRED BUT THE STAPLES DIDN'T HOLD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818497 ↗
• MalfunctionJan 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519560 ↗
• MalfunctionOct 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE STOPPED DURING FIRING. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904949 ↗
• MalfunctionMay 9, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC APPENDECTOMY PROCEDURES THAT THE DEVICE HAS NOT BEEN WORKING TO REALLY SEAL THE VESSELS. ANOTHER OPTION WAS USED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896297 ↗
• MalfunctionMay 9, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC APPENDECTOMY PROCEDURES THAT THE DEVICE HAS NOT BEEN WORKING TO REALLY SEAL THE VESSELS. ANOTHER OPTION WAS USED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895710 ↗
• MalfunctionOct 6, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THERE WERE STAPLE MALFORMATION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550098 ↗
• MalfunctionMar 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER WANTED TO ENSURE ALL ASPECTS OF THE DEVICE WERE INVESTIGATED. NO FURTHER DETAILS REGARDING THE ALLEGED DEFICIENCY WERE REPORTED. THERE WAS NO DELAY TO THE SURGERY OR PATIENT IMPACT. PROCEDURE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869653 ↗
• MalfunctionSep 30, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE FAILED TO FIRE. DIDN'T ACTIVATE AT ALL. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558201 ↗
• MalfunctionJul 8, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, "RESIDENT WENT IN TO USE ENDOPATH ETS45 2.5 MM RELOAD, AND RELOAD WAS DEFECTIVE (DID NOT FIRE ALL THE WAY). RESIDENT AND SURGEON VERIFIED IT DID NOT FIRE CORRECTLY, REMOVED FROM STERILE FIELD AND TAGGED. THE EQUIPMENT WAS NOT USED IN OR ON THE PATIENT." NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134028 ↗
• MalfunctionJun 17, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE RELOAD DID NOT GET FIRED, STAPLE FORMATION DID NOT HAPPEN LEADING TO BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018229 ↗
• MalfunctionMay 11, 2021Structural Problem; Structural Problem

  IT WAS REPORTED THAT 3-4 OF THE STAPLES WERE ALREADY OUT OF STAPLE DECK BEFORE IT WAS BEING ASSEMBLED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805452 ↗
• MalfunctionMar 8, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A VATS LOBECTOMY, A DEVICE LOADING THE TR45W WAS LOCKED OUT AT THE FIRING. THE DEVICE WAS USED ON THE BLOOD VESSEL. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434970 ↗
• MalfunctionJan 19, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC DISTAL GASTRECTOMY SURGERY, COULD NOT FIRE WHEN SEVERING JEJUNUM TISSUE . 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 11197292 ↗
• MalfunctionAug 19, 2020Failure to Fire; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY, THE DEVICE COULD NOT BE FIRED ON THE BLOOD VESSEL. SOME STAPLES AT THE PROXIMAL END OF THE CARTRIDGE WERE PROTRUDED SLIGHTLY FROM THE CARTRIDGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10427977 ↗
• MalfunctionAug 11, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NEPHRECTOMY, THE CARTRIDGE/RELOAD DETACHED FROM THE GUN WHILE FIRING. SURGERY WAS DELAYED 15 MINUTES, BUT WAS SUCCESSFULLY COMPLETED WITH A NEW DEVICE. IT'S UNKNOWN WHETHER THERE WERE ANY PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391415 ↗
• MalfunctionJul 24, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT FIRE FARTHER THAN HALF WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321203 ↗
• MalfunctionJul 24, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT FIRE FARTHER THAN HALF WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321197 ↗
• MalfunctionJul 17, 2020Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RELOAD ONLY FIRED HALFWAY AND THE STAPLER DIDN'T MOVE. SCRUB NURSE REPLACED THE RELOAD AND THE CASE WAS CLOSED WITHOUT FURTHER PROBLEMS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291005 ↗
• MalfunctionApr 3, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN COLORECTAL PROCEDURE, THE RELOAD WOULDN'T FIRE STAPLES WHEN PULLED. A SECOND LIKE RELOAD WAS USED AND FIRED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924202 ↗