ECHELON CIRCULAR CDH23PRecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10705036015369), received between Feb 4, 2020 and Sep 25, 2026 — classified as 16 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (51 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Fire

  It was reported that during an Unknown surgery, could not fire farther after fired a little. 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 50896413 ↗
• InjuryJun 29, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURES, FOUR DIFFERENT PATIENTS HAD TO BRING BACK FOR BLEEDING AT THE STAPLE LINE. THE PATIENTS WERE DOING FINE RIGHT NOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25653591 ↗
• InjuryJun 22, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURES, FOUR DIFFERENT PATIENTS HAD TO BRING BACK FOR BLEEDING AT THE STAPLE LINE. THE PATIENTS WERE DOING FINE RIGHT NOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25585432 ↗
• InjuryJun 19, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING ESOPHAGOJEJUNOSTOMY, DURING USE FOR ESOPHAGOJEJUNOSTOMY, THE INDICATOR WAS ILLUMINATED, BUT THE DEVICE COULD NOT BE FIRED. DUE TO A CHANGE IN THE ANASTOMOTIC TECHNIQUE FOR THE ESOPHAGOJEJUNOSTOMY (FROM CIRCULAR PROCEDURE TO OVERLAP PROCEDURE USING AN END CUTTER), ADDITIONAL RESECTION WAS REQUIRED AND THE OPERATION TIME WAS PROLONGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25561448 ↗
• MalfunctionJun 11, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING USE FOR ESOPHAGEAL ANASTOMOSIS IN OPEN THORACIC SURGERY, FIRING COULD NOT BE PERFORMED. THE ANVIL WAS LEFT IN PLACE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. 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 25476893 ↗
• MalfunctionMay 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, 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 25264717 ↗
• MalfunctionApr 11, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ESOPHAGUS SURGERY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852633 ↗
• MalfunctionApr 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, 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 24770269 ↗
• MalfunctionJan 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 24167444 ↗
• InjuryJan 21, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SAITO A, OTSUKA K, GOTO S, ARIYOSHI T, YAMASHITA T, MOTEGI K, KOMOTO M, KISHIMOTO Y, MURAKAMI M, AOKI T. COMPARISON OF ANASTOMOTIC STRICTURE RATES BETWEEN 23- AND 25-MM POWERED CIRCULAR STAPLERS IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS: A PROPENSITY-MATCHED STUDY. ESOPHAGUS. 2025 DEC 22. DOI: 10.1007/S10388-025-01171-2. EPUB AHEAD OF PRINT. THIS STUDY AIMED TO COMPARE STENOSIS RATES BETWEEN NEWLY INTRODUCED 23- AND 25-MM POWERED CIRCULAR STAPLER (CSS) IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. FROM (B)(6) 2022 TO (B)(6) 2024, 126 PATIENTS WHO UNDERWENT THORACOSCOPIC MCKEOWN ESOPHAGECTOMY WITH RETROSTERNAL GASTRIC CONDUIT RECONSTRUCTION WERE RETROSPECTIVELY ANALYZED. THEY WERE CATEGORIZED INTO THE 23 MM (N = 52) AND 25-MM (N = 74) CS GROUPS. REPORTED COMPLICATIONS INCLUDE THE INCIDENCE OF ANASTOMOTIC STRICTURE WAS 18.0% (7 CASES) AND 12.8% (5 CASES) IN THE 23- AND 25-MM CS GROUPS, RESPECTIVELY. THE INCIDENCE OF ANASTOMOTIC LEAKAGE AND THE LEAKAGE LOCATION REVEALED NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS. IN CONCLUSION, 23- AND 25-MM POWERED CSS ACHIEVED COMPARABLE ANASTOMOTIC STRICTUR

  Patient problems: Failure to Anastomose; Obstruction/Occlusion; Stenosis

  MAUDE report 24137099 ↗
• InjuryJan 21, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SAITO A, OTSUKA K, GOTO S, ARIYOSHI T, YAMASHITA T, MOTEGI K, KOMOTO M, KISHIMOTO Y, MURAKAMI M, AOKI T. COMPARISON OF ANASTOMOTIC STRICTURE RATES BETWEEN 23- AND 25-MM POWERED CIRCULAR STAPLERS IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS: A PROPENSITY-MATCHED STUDY. ESOPHAGUS. 2025 DEC 22. DOI: 10.1007/S10388-025-01171-2. EPUB AHEAD OF PRINT. THIS STUDY AIMED TO COMPARE STENOSIS RATES BETWEEN NEWLY INTRODUCED 23- AND 25-MM POWERED CIRCULAR STAPLER (CSS) IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. FROM MAY 2022 TO FEBRUARY 2024, 126 PATIENTS WHO UNDERWENT THORACOSCOPIC MCKEOWN ESOPHAGECTOMY WITH RETROSTERNAL GASTRIC CONDUIT RECONSTRUCTION WERE RETROSPECTIVELY ANALYZED. THEY WERE CATEGORIZED INTO THE 23 MM (N = 52) AND 25-MM (N = 74) CS GROUPS. REPORTED COMPLICATIONS INCLUDE THE INCIDENCE OF ANASTOMOTIC STRICTURE WAS 18.0% (7 CASES) AND 12.8% (5 CASES) IN THE 23- AND 25-MM CS GROUPS, RESPECTIVELY. THE INCIDENCE OF ANASTOMOTIC LEAKAGE AND THE LEAKAGE LOCATION REVEALED NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS. IN CONCLUSION, 23- AND 25-MM POWERED CSS ACHIEVED COMPARABLE ANASTOMOTIC STRICTURE

  Patient problems: Failure to Anastomose; Obstruction/Occlusion; Stenosis

  MAUDE report 24137086 ↗
• MalfunctionOct 3, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOTED THE JAW LOOSE AND COULD NOT CLAMP THE TISSUE. 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 23208384 ↗
• MalfunctionAug 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, 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 22794257 ↗
• MalfunctionJul 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY SURGERY, 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 22519127 ↗
• MalfunctionMay 19, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN ESOPHAGEAL SURGERY, ANVIL COULD NOT LOCKED ON TROCAR AFTER FIRED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044439 ↗
• MalfunctionApr 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY, THE GREEN CHECK MARK ILLUMINATED WHEN THE BATTERY WAS INSERTED. 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 21738184 ↗
• InjuryMar 31, 2025Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Failure to Eject; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Failure to Eject

  IT WAS REPORTED THAT DURING A MEDIASTINOSCOPIC SUBTOTAL ESOPHAGECTOMY, THE KNOB DID NOT TURN AND THE ANASTOMOSIS COULD NOT BE COMPLETED WHEN THE ANVIL AND THE DEVICE WERE CONNECTED DURING ANASTOMOSIS AND THE KNOB WAS TURNED TO CLOSE. CDH23P WAS USED FOR ANASTOMOSIS OF THE CERVICAL ESOPHAGUS AND GASTRIC TUBE. ADDITIONAL RESECTION WAS PERFORMED AND THE PROCEDURE WAS CHANGED TO HAND-SEWN ANASTOMOSIS BECAUSE THE ANVIL AND THE DEVICE COULD NOT BE SEPARATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21730741 ↗
• MalfunctionFeb 6, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC ESOPHAGECTOMY, THE DEVICE COULD NOT CLOSE AFTER THE ANVIL AND THE TROCAR WERE CONNECTED IN THE ESOPHAGUS FOR CERVICAL ANASTOMOSIS. AND ALSO THE ANVIL AND THE TROCAR COULD NOT SEPARATE, AND CDH WAS REMOVED BY RESECTION. ADDITIONAL HAND SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326405 ↗
• MalfunctionJan 28, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255378 ↗
• MalfunctionJan 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY WHEN FIRING, THE STAPLES COULDN'T BE DEPLOYED. CHANGED ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079226 ↗
• MalfunctionAug 23, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 20054608 ↗
• MalfunctionAug 7, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CDH23P WAS FIRED EVEN THE NODE WAS NOT CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928506 ↗
• MalfunctionJul 15, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGECTOMY, USED DURING ANASTOMOSIS OF ESOPHAGUS AND STOMACH. THE DEVICE COULD NOT BE FIRED WITH PULLING THE FIRING KNOB. NO ELECTROCAUTERY WAS USED IMMEDIATELY PRIOR TO THE PROCEDURE. THERE WAS NOTHING OUT OF THE ORDINARY INCLUDING THE SETTING. 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 19743951 ↗
• MalfunctionJul 8, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS FIRED EVEN THE FIRING TRIGGER WAS NOT PRESSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689137 ↗
• InjuryMay 13, 2024Use of Device Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE FIRE, NOTED THE DEVICE CUT THE TISSUE WITHOUT STAPLE DEPLOYED. CHANGED TO OPEN OPERATION TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

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

  MAUDE report 19297603 ↗