ENDOPATH ATS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,046 adverse event reports that list this exact device (DI 10705036001072), received between Jul 16, 2015 and Sep 28, 2026 — classified as 2 deaths, 109 injuries, 1,934 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (965 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 2,046 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Cut; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923748 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916582 ↗
• MalfunctionSep 24, 2026Failure to Fire; Noise, Audible

  It was reported that during a Laparoscopic Appendectomy procedure, it was observed that the stapler was loud when firing; and the surgeon was only able to fire half of the staple load. There was no patient consequence nor surgical delay reported. Additional information requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882238 ↗
• MalfunctionSep 21, 2026Failure to Cut; Firing Problem

  It was reported that during an unknown procedure, the device attached the white cartridge and tried to fire, but the knife was too hard to move halfway through. The blue cartridge was used and the device could be fired. The cartridge colors were white and bule. Another cartridge was loaded into the same device to complete the case. There were no adverse consequences to the patient. Additional information requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840830 ↗
• MalfunctionSep 17, 2026Failure to Form Staple; No Apparent Adverse Event

  It was reported that during an unknown procedure, it was observed that the staple line did not close properly, causing bleeding in the intra-op, forcing the surgeon to perform cecal appendix raffia. The patient recovered from the procedure and is now well, with no further information. No additional information provided.

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

  MAUDE report 50804125 ↗
• MalfunctionAug 17, 2026Difficult to Open or Close; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286745 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258426 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255749 ↗
• MalfunctionJul 27, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037742 ↗
• MalfunctionJun 19, 2026Failure to Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED AND THE DEVICE MADE A STRANGE CLICKING SOUND. 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 25565771 ↗
• MalfunctionJun 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RELEASE HANDLE ON THE DEVICE BROKE OFF AFTER THE DEVICE WAS SUCCESSFULLY TRIGGERED WITHIN THE ABDOMEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565049 ↗
• MalfunctionJun 8, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT TRIGGER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428194 ↗
• MalfunctionJun 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER JAMMED DURING STAPLING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360679 ↗
• MalfunctionJun 1, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER HAS NOT FULLY FIRED, IT STOPPED IN THE MIDDLE OF THE FIRING CYCLE, THEN STOPPED GOING BACK AND FORTH. IT COULD THEN BE OPENED ONLY BY FORCE. THE STAPLES WERE NOT RELEASED IN THE ABDOMEN AND HAD TO BE REMOVED. A SECOND DEVICE HAD TO BE OPENED, WHICH THEN WORKED WITHOUT ANY PROBLEMS. NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355686 ↗
• MalfunctionMay 28, 2026Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER COULD BE CLOSED, BUT IT DID NOT FIRE PROPERLY. IT COULD BE ACTIVATED, BUT AFTER APPROXIMATELY 1 CM IT GOT STUCK. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IF YES, DESCRIBE CUSTOMER REPORTED "PERFORATION AND BLEEDING".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 25316438 ↗
• MalfunctionMay 14, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER COULD NOT BE FULLY TRIGGERED. THE KNIFE ONLY ADVANCED A FEW MILLIMETERS AND THEN STOPPED. 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 25175612 ↗
• MalfunctionMay 14, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED OUT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175122 ↗
• MalfunctionMay 14, 2026Failure to Fire; Difficult to Open or Close; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TRIGGER ON THE DEVICE DID NOT WORK CORRECTLY, THERE WAS A SOUND AS IF IT WOULD NOT CLOSE, AND THERE WERE PROBLEMS WITH THE KNIFE. 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 25173438 ↗
• MalfunctionMay 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE LOCKING OF THE DEVICE WENT WELL BUT THERE WERE NO STAPLES UPON SQUEEZING THE TRIGGER. THE DEVICE WAS BLOCKED. THERE WAS ALSO NO SUCCESS WITH ANOTHER MAGAZINE. A NEW STAPLER HAD TO BE OPENED AND THE ABLATION WAS SUCCESSFUL. HOWEVER, DUE TO THE CRUSHING AREAS, A COECUM WEDGE RESECTION INSTEAD OF A SIMPLE APPENDECTOMY HAD TO BE PERFORMED ON THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149713 ↗
• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE TRIGGERED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083394 ↗
• MalfunctionMay 4, 2026Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WAS MALFUNCTIONING AND THE JAWS WOULD NOT OPEN OR LOCKED-OUT. THEY COULDN'T PULL THE DEVICE FROM THE TISSUE SO THEY PULLED OUT THE DEVICE WITH THE TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 25072233 ↗
• MalfunctionMay 4, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, IT WAS OBSERVED THAT THEY HAD DIFFICULTIES OPENING STAPLER BACK UP TO RELEASE THE TISSUE AND SPECIMEN. SURGEON INITIALLY COMMENTED THE FIRING DID NOT STAPLE FULLY ACROSS THE TISSUE IT WAS CLOSED ON, THEN VERBALIZED THAT IT STAPLED ACROSS A METAL LIGACLIP. SURGEON REQUESTED ANOTHER STAPLE LOAD. ONCE SCRUB NURSE PROVIDED THE SAME, SURGEON ATTEMPTED TO CLOSE STAPLER BEFORE INSERTING IT INTO THE PORT SITE AND COMMENTED HOW THE STAPLER WAS NOT CLOSING PROPERLY AND REQUESTED A NEW STAPLER. RESIDENT AND SURGEON REPORTED NO ISSUES WITH THE SECOND STAPLER AND COMMENTED THAT IT BOTH "SOUNDED AND FELT BETTER". UPON DEBRIEF OF THE INCIDENT, RESIDENT AND SURGEON STATED THE FIRST STAPLER "FELT FUNKY" PRIOR TO USING IT AND NOTED THAT EVEN INITIALLY THEY HAD DIFFICULTIES OPENING THE STAPLER. THEY STATED THE FIRST STAPLER HAD DIFFICULTIES BOTH OPENING AND CLOSING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069116 ↗
• MalfunctionApr 30, 2026Difficult to Open or Close; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TRIGGER DID NOT WORK CORRECTLY AS THERE WAS A SOUND AND IT WOULD NOT CLOSE. THEY ALSO HAD PROBLEMS WITH THE KNIFE. 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 25047708 ↗
• MalfunctionApr 28, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE LOCKED OUT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020752 ↗
• MalfunctionApr 27, 2026Difficult to Open or Close; Firing Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS DIFFICULT TO FIRE AND GOT STUCK ON THE TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000468 ↗