ECHELON FLEX ENDOPATH EC60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,450 adverse event reports that list this exact device (DI 10705036001706), received between Feb 15, 2013 and Sep 28, 2026 — classified as 8 deaths, 158 injuries, 1,284 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (511 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 1,450 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922225 ↗
• MalfunctionSep 24, 2026Failure to Form Staple

  It was reported that during an unknown procedure, it was observed that some staples were malformed with irregular shape after firing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884269 ↗
• MalfunctionSep 24, 2026Failure to Fire

  It was reported that during an unspecified surgical procedure, it was observed that the device could not be fired. 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 50883667 ↗
• MalfunctionSep 21, 2026Failure to Form Staple

  It was reported that during an unknown procedure, it was observed that the staples were malformed after firing. Changed another one to continue the surgery, the same problem happened again. 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 50840904 ↗
• MalfunctionSep 18, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829278 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50572052 ↗
• MalfunctionAug 31, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520037 ↗
• MalfunctionAug 24, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409591 ↗
• MalfunctionAug 14, 2026Failure to Form Staple; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256259 ↗
• MalfunctionAug 10, 2026Insufficient Device Problem Information

  It was reported that during an unknown procedure, it was observed that the stapler misfired. 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 50195193 ↗
• MalfunctionAug 3, 2026Failure to Fire

  It was reported that during an unknown procedure, the first firing was completed successfully. During the second firing, while closing the common enterotomy, the firing trigger felt light, and firing was completed on the fifth grasping. However, upon checking the surgical field, it was found that no staples had been formed, and the device had not fired properly. The doctor switched to manual suturing to complete the case. The cartridge color was White. There were no adverse consequences to the patient. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115079 ↗
• MalfunctionJul 17, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860425 ↗
• InjuryJul 1, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE PATIENT¿S LOBE WAS DESCRIBED AS THICK, PREVENTING THE STAPLER FROM CLOSING INITIALLY. THE SURGEON SUBSEQUENTLY FORCED THE DEVICE TO CLOSE AND HELD COMPRESSION FOR TWO MINUTES. UPON FIRING, A LOUD POP WAS HEARD, AND THE KNIFE DID NOT ADVANCE FURTHER. TWO PLEE60A DEVICES REQUIRED MANUAL OVERRIDE TO OPEN. ADDITIONALLY, BOTH PLEE60A DEVICES RAN OUT OF BATTERY CHARGE DURING FIRING, AND THE ANVIL ON THE ECH45L AND ECH60 DEVICES WAS NOTED TO BE BENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25681507 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A RADICAL RESECTION OF PANCREATIC CANCER, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25613177 ↗
• MalfunctionJun 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25566412 ↗
• MalfunctionJun 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537620 ↗
• MalfunctionJun 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAP GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. THEY USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511072 ↗
• MalfunctionJun 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25488974 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25447774 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25445921 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER GOT STUCK WHILE FIRING. AS A RESULT, THE SURGEON HAD TO USE A NEW STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444447 ↗
• MalfunctionJun 8, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC PANCREATIC PROCEDURE, IT WAS OBSERVED THAT THE TISSUE WAS NOT CUT AFTER FIRING. 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 25428230 ↗
• MalfunctionJun 1, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25349692 ↗
• MalfunctionJun 1, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 25349430 ↗
• MalfunctionMay 29, 2026Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL GASTRECTOMY PROCEDURE; IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE WHEN SEVERING DUODENAL TISSUE ON THE FIRST FIRING. IT WAS FURTHER REPORTED THAT THEY COULD NOT OPEN THE JAW. AS THE TISSUE WAS CUT OFF, THEY REMOVED THE DEVICE FROM THE PATIENT THROUGH TISSUE GAP. CHANGED ANOTHER ONE TO USE, STILL COULD NOT FIRE. 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 25337509 ↗