ECHELON ECH45SRecalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 10705036035008), received between Feb 23, 2023 and Sep 28, 2026 — classified as 18 injuries, 251 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (101 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 269 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923820 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920027 ↗
• MalfunctionSep 24, 2026Mechanical Jam

  It was reported that during an unspecified surgical procedure, it was observed that the knife did not return after firing. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884632 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884368 ↗
• MalfunctionSep 20, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834823 ↗
• MalfunctionSep 20, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834822 ↗
• MalfunctionSep 18, 2026Failure to Fire; Difficult to Open or Close; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828999 ↗
• MalfunctionSep 18, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824425 ↗
• MalfunctionSep 18, 2026Difficult to Open or Close

  It was reported that during a VATS lobectomy, the surgeon experienced difficulty closing the device. A second device was also utilized in the procedure and difficulty closing was experienced. Both devices were loaded with a green reload which worked as intended. There was no patient consequence reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820372 ↗
• MalfunctionSep 17, 2026Failure to Cut

  It was reported that during a Whipple procedure, the surgeon used the stapler to transect pancreatic tissue. On the first firing, the device formed staples on both sides of the tissue as intended; however, the device failed to cut the tissue. Suspecting that tissue thickness may have contributed to the issue, the user replaced the initial blue reload with a thicker green reload and attempted to fire the device again. The device again stapled but failed to cut the tissue. After three unsuccessful firing attempts with different reloads, a new stapler was opened and used to continue the procedure. No patient consequences were reported. Additional information requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803544 ↗
• MalfunctionAug 26, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459722 ↗
• MalfunctionAug 20, 2026Failure to Form Staple; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347388 ↗
• MalfunctionAug 19, 2026Positioning Failure; Difficult to Open or Close; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324420 ↗
• MalfunctionAug 14, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260388 ↗
• MalfunctionAug 14, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260163 ↗
• MalfunctionAug 14, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

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

  MAUDE report 50254714 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252908 ↗
• MalfunctionAug 6, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161564 ↗
• MalfunctionAug 4, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131258 ↗
• MalfunctionJul 27, 2026Failure to Fire; Difficult to Open or Close; Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019365 ↗
• MalfunctionJul 9, 2026Failure to Form Staple; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762882 ↗
• MalfunctionJul 1, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE MISFIRED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678351 ↗
• MalfunctionJun 25, 2026Positioning Failure; Activation Problem

  IT WAS REPORTED THAT DURING A PEDIATRIC LAP APPENDECTOMY, THE APPENDIX WAS SUCCESSFULLY STAPLED AND FREED BUT THE STAPLER WOULD NOT STRAIGHTEN OUT AND PUSHING THE HOME BUTTON OR ARROW BUTTON. THEY USED THE MANUAL OVERRIDE, BUT BLACK LEVER WAS VERY STUCK. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622248 ↗
• MalfunctionJun 24, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT ARTICULATE BEFORE FIRING. 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 25612749 ↗
• MalfunctionJun 23, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OF THE LIVER, SURGEON WENT TO USE ECHELON 3000 STAPLER AND THE BATTERY DIED - DID NOT HAVE ENOUGH POWER TO FIRE THROUGH ENTIRE ORGAN (LIVER) AND AS A RESULT LEFT A HOLE. REP WAS ON SITE IN THE DAYS FOLLOWING AND SPOKE WITH SURGEON - THE SURGEON SAID THE BATTERY DID NOT SOUND RIGHT - NOT A SLOWING DOWN IN THICK TISSUE BUT A VERY SLUGGISH SOUND AND THEN DIED. SURGEON WAS FIRING ON A VESSEL IN THE LIVER AND WAS VERY ANXIOUS ABOUT THE OUTCOME - USED THE MANUAL OVERRIDE TO REVERSE IT. RESIDENT TOLD ME SEPARATELY BUT DID NOT FORM PROPERLY. SURGEON OPENED A NEW STAPLER AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 25595609 ↗