ECHELON CIRCULAR CDH31PRecalls & reported problems

Summary

The FDA's MAUDE database contains 224 adverse event reports that list this exact device (DI 10705036015390), received between Apr 4, 2019 and Sep 25, 2026 — classified as 81 injuries, 143 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (84 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 224 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Fire

  It was reported that during an anterior resection during colorectal surgery. While attempting to use the device to create an anastomosis, the physician observed that it failed to operate and the green "click" light illuminated. A new device was opened for the anastomosis. There was no adverse event involving the patient. Was there any reported patient or user harm? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896090 ↗
• MalfunctionSep 24, 2026Failure to Fire; Appropriate Device Problem Term/Code Not Available

  It was reported that during an Unknown surgery when they were about to fire CDH31P, the instrument didn't sound or vibrate. A green check mark appeared but no effect on the tissue were noticed. They tried to change battery by opening another instrument and replacing that battery, but with no change in effect. They took out the instrument and replaced it with a new one, then it worked fine. Was there any reported patient or user harm? Yes.Did the patient/user require any medical or surgical intervention as a result of the event? Unknown. Did the patient/user require extended hospitalization as a result of the event? Unknown.What is the patient¿s/user¿s status/outcome following the event? hematoma near the area to be stapled during the swap of instruments.Was there a significant delay? Yes. How long was the delay (minutes)? 30.

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

  MAUDE report 50883436 ↗
• MalfunctionSep 16, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794348 ↗
• MalfunctionSep 3, 2026Mechanical Jam; Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591698 ↗
• MalfunctionSep 2, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562949 ↗
• InjuryAug 5, 2026Patient Device Interaction Problem

  It was reported that post op to an Unknown procedure that the surgeon had a patient present with anastomotic strictures, after using the CDH. He routinely uses CDH31P.

  Patient problems: Insufficient Information

  MAUDE report 50145041 ↗
• MalfunctionAug 5, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144215 ↗
• MalfunctionJun 29, 2026Failure to Fire

  IT WAS REPORTED THAT ANTERIOR RESECTION, STAPLER FAILED TO FIRE DURING ANASTOMOSIS OF BOWEL. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660377 ↗
• MalfunctionJun 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT A FEW UNFORMED STAPLES WERE VISIBLE IN THE BOWEL LUMEN WHEN SCOPING THE ANASTOMOSIS. BOTH DOUGHNUTS WERE INTACT AND LEK TEST WAS NEGATIVE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653138 ↗
• MalfunctionJun 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING ROBOTIC BOWEL RESECTION, ANVIL DOCKED TO STAPLER AND CLOSED, WITH BATTERY INSERTED AND ALL LIGHTS ON, BUT WHEN SAFETY REMOVED AND FIRING TRIGGER DEPRESSED IT DID NOT FIRE. THEATRE STAFF CALLED MYSELF FOR TROUBLESHOOTING. ADVISED TO OPEN THE STAPLER TO CONFIRM COMPLETE DOCKING OF THE ANVIL, REMOVE AND REINSERT BATTERY, AND CLOSE UNTIL THE ORANGE BAR WAS WITHIN THE RANGE WINDOW. STAPLER STILL WOULD NOT FIRE. NEW STAPLER OPENED, AND PROCEDURE COMPLETED WITH NEW DEVICE, WHICH FIRED AS EXPECTED. PROCEDURE DELAYED BY 10 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553506 ↗
• MalfunctionJun 15, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CDH31P REFUSED TO FIRE. ALSO AFTER REPLACING THE BATTERY FROM ANOTHER DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510513 ↗
• MalfunctionMay 15, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THE SURGEON HAD THE STAPLER IN PLACE, IT WAS NOT POSSIBLE TO FIRE IT, THE STAPLE LINE COULD NOT BE RELEASED. HAD TO CHANGE STAPLERS, HIGH RISK OF INTESTINAL DAMAGE. IT HAPPENED WHEN THEY WERE GOING TO STAPLE ANASTOMOSIS TO THE RECTUM (COLON ANASTOMOSIS TO THE RECTUM). THE CONSEQUENCE OF THE PRODUCT NOT WORKING: A NEW STAPLER WAS BROUGHT IN AND THEN IT WENT WELL. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184740 ↗
• MalfunctionMay 7, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LEFT COLON OPERATION, A 31 MM CIRCULAR STAPLER, CODE CDH31P, WAS USED FOR THE ANASTOMOSIS. ONCE THE STAPLER WAS CLOSED AND THE SAFETY CATCH WAS RELEASED, IT DID NOT FIRE. THEY REPLACED THE BATTERY, THINKING IT WAS DEAD, BUT IT STILL DIDN'T WORK. THE RED TRIGGER DIDN'T WORK. THE PROCEDURE WAS DELAYED BY 20 MINUTES AND COMPLETED SUCCESSFULLY. THEY CHANGED TO A NEW STAPLER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117383 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED PROPERLY AND EVERYTHING WENT WELL DURING THE CASE. HOWEVER, PATIENT WHO UNDERWENT PROCEDURE WITHIN A SPAN OF TWO WEEKS EXPERIENCED POST-OPERATIVE LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 25049221 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED PROPERLY AND EVERYTHING WENT WELL DURING THE CASE. HOWEVER, PATIENT WHO UNDERWENT PROCEDURE WITHIN A SPAN OF TWO WEEKS EXPERIENCED POST-OPERATIVE LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 25049185 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED PROPERLY AND EVERYTHING WENT WELL DURING THE CASE. HOWEVER, PATIENT WHO UNDERWENT PROCEDURE WITHIN A SPAN OF TWO WEEKS EXPERIENCED POST-OPERATIVE LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 25049166 ↗
• MalfunctionApr 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A ROBOTIC POUCH CREATION PROCEDURE, THE STAPLER HAD A GREEN CHECKMARK PRIOR TO FIRING AND NEVER FIRED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048664 ↗
• MalfunctionMar 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, POWERED CIRCULAR STAPLER DIDN'T FIRE, SURGEON TRIED MULTIPLE TIMES IN SPITE ON TISSUE RANGE WAS GLOWING. NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719592 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC RECTUM RESECTION PROCEDURE, NOTICED AN INCREASE IN ANASTOMOTIC LEAKAGE IN RECTUM RESECTIONS WHEN SWITCHING FROM MEDTRONIC CIRCULAR MANUAL STAPLER 28 MM TO ECHELON CIRCULAR POWERED STAPLER 31 MM. NO FURTHER DETAILS KNOWN.

  Patient problems: Failure to Anastomose

  MAUDE report 24627287 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC RECTUM RESECTION PROCEDURE, IN ANASTOMOTIC LEAKAGE. PATIENT CONSEQUENCE WERE ANASTOMOTIC LEAKAGES.

  Patient problems: Failure to Anastomose

  MAUDE report 24524971 ↗
• InjuryMar 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A COLORECTAL PROCEDURE, THE DIFFERENT SURGEON AT THE A DIFFERENT LOCATION HAD A PATIENT RETURN WITH POST OPERATION BLEED. THE SURGEON HAD TO TAKE THE PATIENT BACK BUT THEY WERE NOT SURE IF IT WAS DUE TO THE STAPLE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24507388 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLO-RECTAL ANASTOMOSES, REQUIRING A RECOVERY IN THE OPERATING ROOM. THE PATIENTS HAD NO IDENTIFIED RISK FACTORS FOR FISTULIZING, ANASTOMOSES WITHOUT TENSION, WELL VASCULARIZED SEGMENTS AND SATISFACTORY LEAK TEST. FISTULA OCCURRED VERY EARLY (J2) SUGGESTING A TECHNICAL DEFECT ON THE MATERIAL.

  Patient problems: Failure to Anastomose; Fistula

  MAUDE report 24498796 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE FISTULAS DURING COLO-RECTAL ANASTOMOSES HAVE OCCURRED. REQUIRING A RECOVERY IN THE OPERATING ROOM. ANASTOMOSES WITHOUT TENSION, WELL VASCULARIZED SEGMENTS, AND SATISFACTORY LEAK TEST. FISTULA OCCURRED VERY EARLY (J2) SUGGESTING A TECHNICAL DEFECT ON THE MATERIAL.

  Patient problems: Failure to Anastomose; Fistula

  MAUDE report 24491176 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE FISTULAS DURING COLO-RECTAL ANASTOMOSES HAVE OCCURRED. REQUIRING A RECOVERY IN THE OPERATING ROOM. ANASTOMOSES WITHOUT TENSION, WELL VASCULARIZED SEGMENTS, AND SATISFACTORY LEAK TEST. FISTULA OCCURRED VERY EARLY (J2) SUGGESTING A TECHNICAL DEFECT ON THE MATERIAL.

  Patient problems: Failure to Anastomose; Fistula

  MAUDE report 24491139 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANASTOMOTIC LEAK OCCURRED FOLLOWING A ROBOTIC LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE. THE DEVICE USED DURING THE PROCEDURE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN OR EVALUATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure to Anastomose; Post Operative Wound Infection

  MAUDE report 24433125 ↗