ECHELON ECH45LRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705036034964), received between Jun 28, 2023 and Aug 18, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (16 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304380 ↗
• MalfunctionApr 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, IT WAS OBSERVED THAT THERE WAS NO RESPONSE FROM THE FIRING TRIGGER AT THE LAST FIRING FOR THE GJ ANASTOMOSIS WHEN THE SURGEON ATTEMPTED TO FIRE THE STAPLER. THEY REMOVED THE BATTERY AND REINSTALLED THE BATTERY, AUDIBLE FEEDBACK WAS HEARD. THEY TRIED TO ARTICULATE THE DEVICE, IT FUNCTIONED WELL. THEY REASSEMBLED THE RELOAD AND TRIED DRY FIRING OUTSIDE BUT STILL UNABLE TO ACTIVATE THE FIRING TRIGGER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858435 ↗
• MalfunctionMar 26, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO USE THE DEVICE BUT WAS UNABLE TO ARTICULATE IT AS INTENDED. AS A RESULT, THE SURGEON OPENED A SECOND DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704560 ↗
• MalfunctionMar 26, 2026Positioning Failure; Noise, Audible

  IT WAS REPORTED THAT DURING A RATS LEFT UPPER LOBE SEGMENTECTOMY FOR PRIMARY LUNG CANCER, AFTER THE KNIFE MOVED AND THE STAPLES DEPLOYED, THERE WERE THREE TO FIVE CLICKING SOUNDS AS IT RETURNED, AND THE KNIFE DID NOT RETURN FOR A WHILE. IT WAS A PHYSICAL CLICKING SOUND (NOT A MECHANICAL SOUND), AND IT WAS DIFFERENT FROM THE FIVE SOUNDS THAT NORMALLY OCCUR WHEN THE KNIFE REVERSES. IT DID NOT ACTIVATE EVEN THOUGH THE HOME BUTTON. AFTER A WHILE, THE KNIFE RETURNED AUTOMATICALLY. THE MAIN BODY AND CARTRIDGE WERE REPLACED, AND THEN THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE DEVICE WAS USED ON THE LEFT S1 OF THE INTERLOBAR. THE CARTRIDGE COLOR WAS GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704123 ↗
• MalfunctionMar 10, 2026Material Integrity Problem; Noise, Audible; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE SLOWED DOWN WHEN THEY FACED WITH A THICKER TISSUE. THEN THEY HEARD A POP. BLADE DID RETURN TO HOME SO SHE WAS ABLE TO REMOVE FROM ABDOMEN. THEY WENT TO RELOAD DEVICE AND NOTICED THAT THE ANVIL WAS BENT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558336 ↗
• MalfunctionMar 3, 2026Positioning Failure; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON HIT THE HOME BUTTON ON THE STAPLER AFTER THE FIRST FIRING BUT THE ARTICULATION JOINT WOULD NOT STRAIGHTEN OUT SO IT COULD BE REMOVED FROM THE TROCAR IN THE PATIENT'S ABDOMEN. THE STAPLER WAS REMOVED WHILE THE TROCAR WAS STILL ON THE SHAFT OF THE STAPLER. A SECOND DEVICE WAS USED WITH OUT INCIDENT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500298 ↗
• MalfunctionFeb 10, 2026Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CUTTING FUNCTION ON THE DEVICE DID NOT WORK AFTER THE USE OF THE GREEN RELOAD; AND THAT THE STAPLER SIMPLY CLAMPED. THEN AFTER THEY RINSED AND CLEANED THE DEVICE ACCORDING TO THE INSTRUCTIONS, THEY USED ANOTHER RELOAD, BUT NOW THE STAPLER WOULD NOT CLOSE PROPERLY AND THERE WAS A GAP BETWEEN THE JAWS, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307828 ↗
• MalfunctionFeb 6, 2026Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN UROLOGY PROCEDURE, IT WAS OBSERVED THAT THE KNIFE CUT BUT NO STAPLES WERE DEPLOYED AFTER FIRING. MANUAL OVERRIDE WAS USED TO REMOVE THE DEVICE. DURING THE MANUAL RELEASE OF THE DEVICE THE HCP SHREDDED THE POETICAL OF THE PROSTATE AND THE PATIENT LOST 500 MILLILITERS OF BLOOD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 24278395 ↗
• MalfunctionJan 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE AND HAD NO MOTOR SOUND ON THE 1TH FIRING. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY. THE DEVICE STILL WOULD NOT FIRE AND HAD NO MOTOR SOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. OUR CUSTOMER SUSPECT IT WAS BATTERY ISSUE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027985 ↗
• MalfunctionDec 2, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER FAILED WITH SOME GUARD ATTACHED. IT CLOSED BUT DID NOT DEPLOY STAPLES AND WOULD NOT REOPEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693328 ↗
• MalfunctionOct 15, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LUNG VOLUME REDUCTION PROCEDURE, THE STAPLER LOCKED TO OPEN, AND IT WAS NECESSARY TO FORCE THE OPENING OF THE HANDLE. IN THE TISSUE THERE WAS PARTIAL STAPLING WITH THE GREEN LOAD THAT STAPLED TO HALF, AND LATER WITH THE BLACK LOAD STAPLED 1/3 OF THE LOAD. IT WAS NECESSARY TO CHANGE THE STAPLER TO CONTINUE AND 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 23280844 ↗
• MalfunctionOct 12, 2025Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE WAS NOT FIRING PROPERLY; AND JAWS WERE STUCK AND WOULD NOT OPEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275649 ↗
• InjuryOct 7, 2025Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LUNG RESECTION, THAT AFTER CLOSING THE ARTICULATED STAPLER TO START THE SHOTS IN THE LUNG, THE SAME BRAKE STOPPED BEFORE THE SHOT WAS NOT POSSIBLE TO REOPEN. AFTER ATTEMPTS TO STIR THE REVERSE AND CHANGE THE POLARITY OF THE BATTERY, THE OPENING SECURITY MECHANISM HAD TO BE TRIGGERED - BLACK LEVER - AND AFTER A FEW ATTEMPTS THE STAPLER OPENED. THIS HANDLING CAUSED A "INJURY" IN THE LUNG. PATIENT HAD MORE AIR FLIGHT BEING NECESSARY ANOTHER DAY OF DRAIN AND CTI.

  Patient problems: Pneumothorax; Unspecified Tissue Injury

  MAUDE report 23233646 ↗
• MalfunctionAug 15, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ECH45L WAS LOADED WITH GST45W, SITTING ON THE MAYO STAND, NOT BEING TOUCHED BY ANYONE OR TOUCHING ANY OTHER DEVICES OR INSTRUMENTS. ECH45L FIRED ON ITS OWN AND COMPLETED A FULL FIRING SEQUENCE. THE DEVICE HAD NOT YET BEEN USED INSIDE THE PATIENT. THE RELOAD THAT WAS IN THE DEVICE AND FIRED WAS GOING TO BE THE FIRST FIRING FOR THE ECH45L. THE SURGICAL TEAM STATED THAT THE RED SAFETY WAS ENGAGED AND NOT OFF DURING THIS OCCURRENCE. SURGEON WAS WORKING AT THE ROBOTIC CONSOLE AND STATES HE WAS THE CLOSEST ONE TO THE DEVICE AT THE TIME AND HEARD IT FIRE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819672 ↗
• MalfunctionDec 6, 2024Unintended Ejection; Material Integrity Problem; Firing Problem; Unintended Ejection; Material Integrity Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION PROCEDURE AT THE SECOND FIRING TRANSECTING LOWER RECTUM IN PELVIS, A GST45B RELOAD WAS USED. SURGEON WAITED 15 SECONDS AFTER CLOSURE BEFORE FIRING FOR TISSUE COMPRESSION. MOTOR SLOWED TO A STOP DUE TO THICK TISSUE, PULSE FIRING WAS USED TO COMPLETE THE TRANSECTION AND KNIFE BLADE RETURNED. NO OBVIOUS ISSUE WITH STAPLE LINE. STAPLER WAS RELOADED WITH CARTRIDGE FOR SUBSEQUENT FIRING BUT DURING PLACEMENT ON RECTUM, CARTRIDGE FELL OUT OF STAPLER. STAPLER AND CARTRIDGE WERE REMOVED, NURSE NOTICED STAPLER ANVIL WAS SLIGHTLY BENT. NEW STAPLER AND CARTRIDGE WERE OPENED TO COMPLETE TRANSECTION. CDH29P WAS SUBSEQUENTLY USED TO COMPLETE ANASTOMOSIS, VISUAL INSPECTION BY ENDOSCOPE OF STAPLE LINE WAS GOOD, AIR LEAK TEST WAS NEGATIVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864843 ↗
• MalfunctionNov 6, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN PRE-FIRING THE DEVICE HAD NO POWER GENERATING AS IF THE BATTERY WAS INEFFECTIVE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622111 ↗
• MalfunctionNov 1, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A BARIATRIC ROUX-EN-Y GASTRIC BYPASS, WHILE USING THE ECH45L, WHEN THE DOCTOR OPENED THE JAWS AFTER FIRING IT APPEARED THERE WERE STAPLES THAT DIDN'T FORM AND WERE STUCK IN THE RELOADS. THE PROXIMAL PART OF THE RELOAD PULLED OUT OF THE STAPLER CHANNEL/JAW. CASE WAS COMPLETED. NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586821 ↗
• MalfunctionSep 11, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; CUSTOMER CLOSED DOWN ON TISSUE, WAITED 15 SECONDS AND FIRED DEVICE. TISSUE WAS STAPLED AND TRANSECTED. AS DEVICE WAS RETURNING TO THE HOME POSITION THEY HEARD A POPPING SOUND. DEVICE WAS OPENED AND REMOVED FROM TISSUE. AS CST WAS TRYING TO REMOVE DEVICE FROM ABDOMEN THEY COULD NOT CLOSE DEVICE. AFTER MULTIPLE ATTEMPTS HE WAS FINALLY ABLE TO CLOSE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190651 ↗
• MalfunctionSep 6, 2024Difficult to Open or Close; Firing Problem; Difficult to Open or Close; Firing Problem

  IT WAS REPORTED THAT DURING A ROBOTIC PROSTATES DVC PROCEDURE; THEY WERE ABLE TO STAPLE THE TISSUE, ALTHOUGH DEVICE DID SLOW DOWN DURING FIRING. KNIFE BLADE RETRACTED AND THEY WERE ABLE TO OPEN JAWS TO GET OFF TISSUE. ONCE THEY TRIED TO CLOSE TO REMOVE FROM BODY THRU THE TROCAR, THEY COULD NOT GET THE DEVICE TO CLOSE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157338 ↗
• MalfunctionSep 5, 2024Delivered as Unsterile Product; Appropriate Device Problem Term/Code Not Available; Delivered as Unsterile Product; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE LAP APPENDECTOMY PROCEDURE THAT UPON OPENING THE DEVICE A "MOISTURE" LIKE FILM WAS INSIDE THE CLEAR PLASTIC SLEEVE THAT COVERS MOST OF THE JAW. TWO DEVICES WERE OPENED IN THE PROCEDURE WITH THIS "MOISTURE" LIKE FILM. A THIRD LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. AFTER THE PROCEDURE THEIR INVENTORY WAS CHECKED AND ANOTHER THREE WERE FOUND TO HAVE THIS SUBSTANCE ON THEM AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152774 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY, THAT AFTER FIRING STAPLES WITHOUT ISSUE, BUT THE PATIENT HAD TO COME BACK DUE TO LOSING 1.5-LITERS OF BLOOD FROM THE STAPLE LINE. THE STAPLE LINE DID APPEAR TO BE DRY WHEN CLOSING. THE USED SURGICEL POWDER TO STOP PATIENT BLEEDING WITHOUT ANY MORE ISSUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20091406 ↗
• MalfunctionJul 24, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A WEDGE RESECTION, THE SURGEON HAD ISSUES CLAMPING DOWN BUT WAS ABLE TOO. THREE TIMES THEY EXPERIENCED A LOCK OUT. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821911 ↗
• MalfunctionJul 11, 2024Component or Accessory Incompatibility; Difficult to Open or Close; Material Integrity Problem; Component or Accessory Incompatibility; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED BY THE SCRUB TECH FIRST ASSIST: DURING ROBOTIC CASE, ECH45L WAS LOADED AND PLACED DOWN TROCAR, OPENED, ARTICULATED AND CLAMPED ON TISSUE. FIRING SEQUENCE WAS COMPLETED, JAWS WERE OPENED AND REMOVED OFF TISSUE. CST-FA WAS UNABLE TO RETURN ANVIL TO HOME POSITION IN ORDER TO REMOVE THE DEVICE THROUGH TROCAR. TROUBLESHOOTING SEQUENCE FOLLOWED, ANVIL STILL ARTICULATED. TROCAR WAS COMPLETELY REMOVED TO REMOVED THE STAPLER SUCCESSFULLY. NO HARM TO PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723630 ↗
• MalfunctionJun 26, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE THAT WHILE STAPLER WAS ARTICULATED AND CLAMPED ON APPENDIX DURING FIRING CYCLE THE KNIFE FAILED TO ADVANCE FULL TRAVEL. MANUAL OVERRIDE WAS USED TO WITHDRAW THE KNIFE BLADE. UNKNOWN WHAT OTHER TROUBLE SHOOTING STEPS MAY HAVE BEEN TAKEN PRIOR TO USING MANUAL OVERRIDE. CONDITION OF THE STAPLE LINE WAS NOT PROVIDED. IT IS UNKNOWN IF ANOTHER STAPLER WAS NEEDED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614230 ↗
• MalfunctionMay 17, 2024Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Material Integrity Problem; Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT THE STAPLER LOADED WITH GRAY LOAD FOR LAP CASE, PLACED ON TISSUE AND CLOSED, PULLED TRIGGER AND FIRED. WENT TO OPEN BUT HAD RESISTANCE. AFTER COUPLE MORE OF ATTEMPTS, JAWS OPENED. PUSHED HOME BUTTON BUT WOULD NOT STRAIGHTEN. RETRIED PUSHING HOME BUTTON MULTIPLE TIMES, DID NOT STRAIGHTEN. REMOVED BATTERY AND REPLACED, WOULD NOT STRAIGHTEN. HAD TO REMOVE TROCAR COMPLETELY TO GET STAPLER OUT OF ABDOMEN. STAPLE LINE APPEARS INCOMPLETE WITH MALFORMED STAPLES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340576 ↗