ECHELON FLEX PLEE45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10705036015345), received between Apr 4, 2018 and Sep 30, 2026 — classified as 2 deaths, 12 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (29 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 96 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 50948834 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 50948816 ↗
• InjurySep 28, 2026Insufficient Device Problem Information; Noise, Audible

  Patient problems: Insufficient Information

  MAUDE report 50919812 ↗
• MalfunctionSep 28, 2026Failure to Fire; Insufficient Device Problem Information

  It was reported that during an unspecified surgical procedure, it was observed that the stapler crashed at the time of the procedure and no longer worked, even performing the reset procedures. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917041 ↗
• MalfunctionJun 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GUN WAS NOT WORKING BUT BATTERY SOUND WAS COMING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566313 ↗
• MalfunctionApr 27, 2026Material Integrity Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A BARIATRIC SLEEVE GASTRECTOMY, THEY WERE USING PLEE45A & FIRED A GOLD RELOAD. WHEN THE GOLD RELOAD WAS REMOVED FROM THE STAPLER AND SWISHED, THEY NOTICED THAT THERE WERE SEVERAL ORANGE DRIVERS IN THE BASIN AND ON THE TABLE. WHEN THE TECH WENT TO RELOAD THE STAPLER, THE 45MM BLUE RELOAD WOULD NOT FIT IN THE STAPLER TO THE POINT HE SHOWED AND THOUGHT MAYBE HE WAS TRYING TO PLACE A 60MM BLUE RELOAD BUT THAT WASN¿T THE CASE, WHEN HE LOOKED INSIDE AT THE KNIFE BLADE, IT WAS NOTICED THAT THERE WERE MORE OF THE ORANGE DRIVERS THAT WERE PREVENTING THE STAPLER FROM RECEIVING THE BLUE 45 RELOAD. SO HE PULLED THE PIECE OUT WITH TWEEZERS AND RINSED THEM OUT AS WELL. THEN SUCCESSFULLY PLACED THE NEW LOAD IN. THE STAPLER FIRED FINE. THE SURGEON DID TAKE OUT A FEW OF THE EXTRA DRIVERS FROM THE PATIENTS ABDOMEN. HE FOUND THREE IN THERE. THEY HAVE NEVER SEEN THIS BEFORE. NO DELAY OR PATIENT CONSEQUENCES WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004581 ↗
• MalfunctionMar 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER JAMMED AND THE BOLT DID NOT FIRE WHEN IT WAS ABOUT TO FIRE. IT WAS NECESSARY TO REPLACE THE STAPLER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650092 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A BYPASS PROCEDURE THERE WAS A PATIENT WHO HAD BLEEDING INTO THE STOMACH. I ASKED HIM TO TELL ME MORE ABOUT HIS PERCEPTIONS ABOUT THE CAUSE OF BLEEDING AND HE STARTED BY SAYING THAT HE HAS BEEN DOING BARIATRIC SURGERY FOR MORE THAN 20 YEARS AND STARTED USING OUR ATS, BUT HE BELIEVES THAT THE PROBLEM WAS BECAUSE JOHNSON DID NOT EVOLVE TO THE TRI-STAPLE SYSTEM WHERE HE BELIEVED THIS WAS THE REASON BECAUSE HE DOES NOT HAVE THIS STATISTIC WITH MATERIALS WITH THIS CHARACTERISTIC. FIRST, I ASKED HIM FOR PATIENT DATA AND A REPORT ON WHAT HAPPENED SO THAT WE COULD LOCATE THE MATERIALS, ALTHOUGH IT IS NOT POSSIBLE TO ANALYZE THE MATERIALS INVOLVED DUE TO DISPOSAL, WE WILL MAKE A REPORT TO THE COMPETENT BODIES AND WE COULD TRACK PROBLEMS REPORTED IN OTHER LOCATIONS OF THE SAME LOT. I WENT ON TO INFORM THAT IN THE SURGERY IN WHICH HIS ASSISTANT THAT WAS TAKING PLACE CONCOMITANTLY IN ANOTHER ROOM, I SIGNALED THAT THE DOCTOR WAS NOT RESPECTING THE PROXIMAL LIMIT OF THE TISSUE IN THE STAPLER'S JAW, WHERE TISSUE WAS BEYOND MARKING, WHERE HE WOULD BE AT RISK OF CUTTING WITHOUT A STAPLE, DR. CONFIRMED DURING THIS CONVERSATION THAT THE TEAM'S CONCERN IS REGARDING THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24079286 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A BYPASS PROCEDURE THERE WAS A PATIENT WHO HAD BLEEDING INTO THE STOMACH. I ASKED HIM TO TELL ME MORE ABOUT HIS PERCEPTIONS ABOUT THE CAUSE OF BLEEDING AND HE STARTED BY SAYING THAT HE HAS BEEN DOING BARIATRIC SURGERY FOR MORE THAN 20 YEARS AND STARTED USING OUR ATS, BUT HE BELIEVES THAT THE PROBLEM WAS BECAUSE (B)(6) DID NOT EVOLVE TO THE TRI-STAPLE SYSTEM WHERE HE BELIEVED THIS WAS THE REASON BECAUSE HE DOES NOT HAVE THIS STATISTIC WITH MATERIALS WITH THIS CHARACTERISTIC. FIRST, I ASKED HIM FOR PATIENT DATA AND A REPORT ON WHAT HAPPENED SO THAT WE COULD LOCATE THE MATERIALS, ALTHOUGH IT IS NOT POSSIBLE TO ANALYZE THE MATERIALS INVOLVED DUE TO DISPOSAL, WE WILL MAKE A REPORT TO THE COMPETENT BODIES AND WE COULD TRACK PROBLEMS REPORTED IN OTHER LOCATIONS OF THE SAME LOT. I WENT ON TO INFORM THAT IN THE SURGERY IN WHICH HIS ASSISTANT THAT WAS TAKING PLACE CONCOMITANTLY IN ANOTHER ROOM, I SIGNALED THAT THE DOCTOR WAS NOT RESPECTING THE PROXIMAL LIMIT OF THE TISSUE IN THE STAPLER'S JAW, WHERE TISSUE WAS BEYOND MARKING, WHERE HE WOULD BE AT RISK OF CUTTING WITHOUT A STAPLE, DR. CONFIRMED DURING THIS CONVERSATION THAT THE TEAM'S CONCERN IS REGARDING THE A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24079284 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE BATTERY WAS DEAD WHEN THEY PUT IT ON AND THERE WAS NO POWER GOING TO THE DEVICE. 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 23696245 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLER MALFUNCTIONED; AND THAT IT WOULD NOT FIRE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693899 ↗
• MalfunctionNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE MISFIRED AND IT GRASPED TOO MUCH TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466508 ↗
• MalfunctionAug 18, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, WHEN THEY FIRED THE STAPLE IT STOPPED HALFWAY THROUGH. IT DID NOT DEPLOY AND IT WAS LOCKED OUT. A MANUAL OVERRIDE WAS PERFORMED TO TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833406 ↗
• MalfunctionAug 18, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLER STOPPED HALFWAY THROUGH WHEN FIRED. IT DID NOT DEPLOY AND IT WAS LOCKED OUT. A MANUAL OVERRIDE WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828613 ↗
• MalfunctionJul 25, 2025Failure to Fire; Difficult to Open or Close; Insufficient Device Problem Information; Failure to Fire; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS MISFIRING AND BECAME STUCK IN THE PATIENT AND WOULD NOT RELEASE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612704 ↗
• MalfunctionJul 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. 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 22470784 ↗
• MalfunctionJul 1, 2025Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLER DID NOT WORK PROPERLY. IN THE FIRST CLIPPING, PARTS OF THE TISSUE HAD STAPLES WHILE OTHERS DID NOT. ALSO, SOME PARTS OF THE TISSUE WERE CUT AND OTHERS WERE NOT. THE DOCTOR ALSO REPORTED THAT SHE HEARD AN UNUSUAL NOISE WHEN THE BLADE WAS RETURNING. 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 22375340 ↗
• MalfunctionApr 30, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OMEGA LOOP PROCEDURE, THE INSTRUMENT COULD NOT BE USED. REMAINS NONFUNCTIONAL AFTER INSERTION. SUSPICION FOR BATTERY CONTACT FAILURE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939253 ↗
• MalfunctionNov 25, 2024Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE MAGAZINE FELL OUT OF THE STAPLER IN THE SITUS, ALTHOUGH IT WAS INSERTED CORRECTLY; AND IT SAT VERY LOOSELY IN THE STAPLER. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772955 ↗
• MalfunctionSep 13, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO A GASTRIC BYPASS PROCEDURE THAT WHILE GETTING READY FOR THE CASE THE STAPLER WAS CLOSED BUT WAS UNABLE TO BE REOPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE OR SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215589 ↗
• MalfunctionJul 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SURGEON ATTEMPTED TO FIRE AND IT PARTIALLY WENT AND STOPPED. USED THE REVERSE KNIFE BLADE AND WAS ABLE TO OPEN AND REMOVE FROM PATIENT. OPENED NEW STAPLER TO COMPLETE FIRING OF THE GJ ANASTOMOSIS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683280 ↗
• MalfunctionJul 5, 2024Failure to Fire; Difficult to Open or Close; Activation Failure; Failure to Fire; Difficult to Open or Close; Activation Failure

  ON 4TH ACTIVATION THE KNIFE ENGAGED- AND THEN STOPPED. REVERSE DIDN¿T WORK. ASKED SURGEON IF HE PULLED BATTERY AND RETRIED - HE DID NOT BUT USED THE MANUAL BAILOUT TO OPEN DEVICE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679319 ↗
• MalfunctionJun 14, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE DEVICE LOCKED ON TISSUE AND WAS UNABLE TO BE REMOVED FROM THE ARTERY DURING A ROBOTIC NEPHRECTOMY PROCEDURE. THEY EXTENDED OPERATING TIME BY 2 HOURS TO CUT THE STAPLER OUT OF THE TISSUE. THEY WERE ABLE TO COMPLETE THE REST OF THE CASE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538765 ↗
• MalfunctionJun 3, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT WHEN PRODUCT WAS TAKEN OUT OF BOX, THE STERILE SEAL WAS RIPPED OPEN ALREADY. BATTERY WAS INSERTED AND MANUAL OVERRIDE WAS PULLED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454177 ↗
• MalfunctionMar 29, 2024Failure to Fire; Difficult to Open or Close; Activation Failure; Failure to Fire; Difficult to Open or Close; Activation Failure

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, DURING THE FIRST FIRING THE MOTOR PAUSED FOR AN UNUSUALLY LONG TIME AND THEN RESTARTED AGAIN. THE DEVICE WAS THEN RELOADED AND WHEN THE SURGEON WENT TO FIRE THE DEVICE, BUT IT WOULD NOT FIRE AND POTENTIALLY LOCKED OUT. THE SCRUB THINKS THE SURGEON TRIED THE REVERSE KNIFE BUTTON, BUT THIS DIDN¿T WORK AND THEN THEY USED THE MANUAL OVERRIDE AND GOT A NEW ECHELON TO COMPLETE THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006325 ↗