Evolution G52225Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522258), received between Apr 1, 2019 and May 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER ADVANCED THE STENT DELIVERY SYSTEM THROUGH WIRE GUIDE AND OVER ESOPHAGEAL FISTULA, THEN DEPLOY THE STENT SUCCESSFULLY. ON (B)(6) 2025 INSPECTION, USER FOUND OUT THE UPPER END (THE END NEAR MOUTH) CAUSE CIRCULAR ULCER, AND DISTAL END OF STENT (END NEAR ANAL SIDE) INSERTED INSIDE THE ESOPHAGEAL MUCOSA AND THE ENTIRE MUCOSA TORE OFF. THE STENT WAS REMOVED FROM PATIENT AND TREATMENT FOR ULCERS WAS ARRANGED FOR PRIORITY. THE STENT WAS REMOVED FROM PATIENT AND TREATMENT FOR ULCERS WAS ARRANGED FOR PRIORITY. COULD IT BE CONFIRMED IF THE PRODUCT IS TO BE RETURNED AS THE CC FORMS IN THE FILE/ AND (B)(6) ARE CONFLICTING? PRODUCT CAN BE RETURNED. WHAT TRIGGERED THE NEED FOR A RE-EXAMINATION ON THE (B)(6) 2025? PATIENT WAS NOT FEELING WELL. WHAT WAS THE DATE OF THE INITIAL STENT PLACING PROCEDURE? (B)(6) 2025. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT WAS REPORTED IN (B)(6)? 14 DAYS. WHAT WAS THE TARGET LOCATION? MIDDLE AND LOWER OF ESOPHAGUS DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIO

  Patient problems: Ulcer

  MAUDE report 22113223 ↗
• MalfunctionJan 19, 2022Improper or Incorrect Procedure or Method; Activation Problem; Improper or Incorrect Procedure or Method; Activation Problem

  USER ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE TO DESIRED POSITION THEN RELEASE THE STENT(REACHED POINT OF NO RETURN), AND DETERMINED THE STENT POSITION IS CORRECT. USER THEN PULLED OUT THE SAFETY WIRE AND RELEASE THE STENT COMPLETELY. USER RETRACTED THE DELIVERY SYSTEM AFTER STENT RELEASE , BUT FOUND OUT THE STENT STUCK ON DELIVERY SYSTEM AND RETRACTED AS WELL. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." "GENERAL QUESTIONS: 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) REMOVING THE INTRODUCER EVOLUTION 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS GIF-XQ260 GIF-XQ260. 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? METII

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289313 ↗
• MalfunctionApr 14, 2020Break; Activation, Positioning or Separation Problem

  USER ADVANCED THE DEVICE OVER WIRE GUIDE TO DESIRED POSITION, THEN USER REMOVED THE RED SAFETY AND PRESS THE TRIGGER TO RELEASE THE STENT. BUT THE STENT CANNOT BE RELEASED, THEN USER PULLED THE SAFETY WIRE OUT AND STILL CANNOT RELEASE THE STENT. USER RETRACTED THE DEVICE AND CHANGED ANOTHER SIMILAR DEVICE FROM A CHINESE DOMESTIC BRAND TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9958557 ↗
• MalfunctionApr 1, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM.¿ USER PULL THE TRIGGER BUT THE STENT WAS NOT RELEASED. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469146 ↗