ECHELON ECH45CRecalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10705036034995), received between Jun 22, 2023 and Sep 28, 2026 — classified as 5 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (69 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 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fire

  It was reported that, during an unknown respiratory surgery, the device did not activate due to battery discharge or a poor connection. 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 50917407 ↗
• MalfunctionSep 21, 2026Failure to Form Staple; Failure to Cut; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845453 ↗
• MalfunctionSep 21, 2026Ejection Problem; Firing Problem

  It was reported that during an unknown procedure, when the black nail (GST45T) was applied to the electric gun (ECH45S), it could not fire smoothly. However, when removing the nail, the black nail also disintegrated. The nurse explained that this was the correct way to remove the nail. After removing the black nail, they tried installing another green nail, which (GST45G), but found that the electric gun was also unusable. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840215 ↗
• MalfunctionSep 18, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820332 ↗
• MalfunctionSep 17, 2026Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804162 ↗
• MalfunctionSep 15, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778295 ↗
• MalfunctionAug 28, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502310 ↗
• MalfunctionAug 20, 2026Device Remains Activated; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347239 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255380 ↗
• MalfunctionAug 14, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252937 ↗
• MalfunctionAug 7, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176675 ↗
• MalfunctionAug 6, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160210 ↗
• MalfunctionJul 9, 2026Failure to Form Staple; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762669 ↗
• MalfunctionJun 18, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC PROCEDURE, THE JAWS INADVERTENTLY CLAMPED A LUNG GRASPING FORCEPS, AND THE DEFORMATION OF THE JAWS AND THE CARTRIDGE WAS NOTED DURING FIRING FOR WEDGE RESECTION. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25551572 ↗
• MalfunctionJun 2, 2026Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING CARTRIDGE LOADING, THE CARTRIDGE COULD NOT BE LOADED INTO THE JAW PROPERLY. ANOTHER NEW ECHELON COULD LOAD THE SAME CARTRIDGE WITH NO PROBLEM, AND THE DEVICE COULD BE USED. 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 25363507 ↗
• MalfunctionApr 29, 2026Failure to Form Staple; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SAME ECHELON 3000 WAS FIRED WITH TWO RELOADS WITHOUT ANY DIFFICULTY. HOWEVER, FOR FOLLOWING FIRING, THE STAPLE DID NOT COME OUT AND TISSUE WAS NOT CUT. THE THIRD RELOAD WAS GST45D, THE FOURTH RELOAD WAS GST45D, AND THE FIFTH RELOAD WAS GST45G. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 25028388 ↗
• MalfunctionApr 28, 2026Difficult to Open or Close; Insufficient Device Problem Information; Noise, Audible

  IT WAS REPORTED THAT DURING A THORACOSCOPY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE PRESENTED SQUEAKING NOISE WHILE STAPLING. IT WAS FURTHER REPORTED THAT THE DEVICE LOCKED DESPITE REVERSE AND FORWARD MOTION. 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 25020173 ↗
• MalfunctionApr 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THEY WERE UNABLE TO FIRE THE STAPLER, AND IT WAS STUCK WHEN THEY OPENED THE JAWS AFTER PRESSING THE RETURN BUTTON. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912169 ↗
• MalfunctionApr 13, 2026Failure to Form Staple; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE KNIFE MOVED FORWARD FOR A MOMENT, BUT THEN REPEATEDLY STOPPED AND MOVED FORWARD, AND THE KNIFE DID NOT MOVE FORWARD EASILY AT THE FIRST FIRING AFTER OPENING THE PACKAGE AND WHILE TRANSECTING THE BRONCHUS. WHEN REACHING THE TIP OF THE JAW AND RETURNING, THE KNIFE RETURNED THE SAME MOVEMENT, WITH REPEATEDLY STOPPED AND MOVED FORWARD. AFTER OPENING THE JAW AND CHECKING THE STAPLES, THE STAPLES WERE MALFORMED. THE CARTRIDGE COLOR WAS WHITE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pneumothorax

  MAUDE report 24865027 ↗
• MalfunctionApr 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR ATTEMPTED TO CLAMP THE TISSUE AND FIRE BUT THE KNIFE DID NOT MOVE FORWARD. THE CARTRIDGE COLOR WAS GREEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858942 ↗
• MalfunctionApr 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A SINGLE-PORT PARTIAL LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT STAPLES WERE NOT DEPLOYED ON ONE SIDE AT THE SECOND FIRING. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847367 ↗
• MalfunctionApr 10, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN RESPIRATORY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841020 ↗
• MalfunctionMar 31, 2026Failure to Fire; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN OPEN RESPIRATORY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS LOCKED OUT AT THE 2ND FIRING WHEN RESECTING THE LUNG. APPARENTLY, THERE WERE NO SLEDS ATTACHED. THE CARTRIDGE COLOR WAS BLUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746612 ↗
• MalfunctionMar 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE STOPPED WORKING AFTER EIGHT FIRINGS. IT GOT STUCK. THE BATTERY WAS NO LONGER FUNCTIONING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703871 ↗
• MalfunctionMar 26, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE PROPERLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702304 ↗