Evolution G23126Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002231266), received between Dec 20, 2018 and Oct 30, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Break; Break

  DESCRIPTION OF EVENT: DURING ERCP STENT PLACEMENT, USER ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE TO DESIRED POSITION AND START TO RELEASE ACCORDING TO IFU, BUT FOUND OUT THE STENT CANNOT BE DEPLOYED. USER RETRACTED THE DEVICE AND FOUND OUT THE PUSHING SHEATH ( FLEXOR)BROKEN. USER CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. PATIENT OUTCOME "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." PATIENT/EVENT INFO - NOTES ADD INFO REQUESTED 20-AUG-2025 UPDATED ON 29AUG2025 WHAT WAS THE POSITION OF THE ELEVATOR? CLOSED DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? ACRO-35-450 WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES DID ANY PART OF THE STENT CONTACT THE PATIENT'S ANATOMY WHEN THE COMPLAINT OCCURRED? YES PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COMMON BILE DUCT WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G., KINK)? NO PLEASE PROVIDE THE STATUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424484 ↗
• MalfunctionNov 28, 2022Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF LAB EVALUATION ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868648 ↗
• MalfunctionAug 4, 2022Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  INFORMATION AS OF (B)(6) 2022: SYSTEM WAS PLACED IN BILE DUCT AND STENT WAS RELEASED. ON REMOVING SAFETY WIRE ON ABOUT 30 CM RESISTANCE WAS FELT AND COULDN'T BE TAKEN OUT FURTHER. AFTER TAKING OUT SAFETY WIRE COMPLETELY, STENT COULD BE RELEASED. AFTER FINISHING PROCEDURE, A METAL PIN WAS DISCOVERED AT PORT ENTRY. LAB EVALUATION (B)(6) 2022. VISUAL INSPECTION: PROTECTIVE TUBING IN PLACE ON RETURN. RED MARKER ON SECOND LAST DIMPLING ON RETURN. LOCK WIRE NOT RETURNED. CANNULA EXPOSED AT THE BACK OF THE HANDLE . INTRODUCER EXPOSED ON RETURN , NO STENT RETURNED. FUNCTIONAL INSPECTION: HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE OF INTRODUCER. 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. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? 4.2 MM. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0,035 INCH, JAGWIRE, BSCI. WAS THE ZIP PORT FACING UPWARDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162435 ↗
• MalfunctionFeb 2, 2021Deformation Due to Compressive Stress; Separation Problem; Deformation Due to Compressive Stress; Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11266842 ↗
• MalfunctionOct 24, 2019Defective Component; Activation, Positioning or Separation Problem; Defective Component; Activation, Positioning or Separation Problem

  AS PER CC FORM: "THE CUSTOMER START TO DEPLOY THE STENT BUT IT DID NOT OPEN. ONLY THE SAFETY WIRE WENT OUT OF THE HANDLE. THEY RECAPTURE THE STENT , FIXED THE SAFETY WIRE AND STARTED AGAIN. NOW IT WORKED, THE STENT OPENED AND ON THE POINT OF NO RETURN THE TRIED TO REMOVE THE SAFETY WIRE. UNFORTUNATELY IT WAS NOT POSSIBLE. THE SAFETY WIRE RIPPED OFF".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9232628 ↗
• MalfunctionFeb 26, 2019Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  THIS FOLLOW UP MDR REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. THIS FILE IS RELATED TO PR (B)(4) AND WAS CREATED TO CAPTURE THE OFF LABEL USE NOTED IN THE ORIGINAL FILE. STENT IN STENT ¿ OFF LABEL USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8370685 ↗
• MalfunctionDec 20, 2018Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS FILE 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" AND "SAFETY WIRE BREAKAGE." PER COMPLAINT FORM: "GOAL WAS TO PLACE A LONGER EVOLUTION BILIARY STENT THROUGH THE COVERED VIAL STENT THAT WAS ALREADY IN PLACE -AFTER TRAVERSING VIABLE COVERED STENT WITH GUIDE WIRE AND EVOLUTION METAL STENT - STENT WAS PARTIALLY DEPLOYED AND RECAPTURED ONCE - THEN WHEN ATTEMPTING TO DEPLOY STENT ( THEY DID GO PAST THE POINT OF NO RETURN A SMALL AMOUNT ) THEY WERE UNABLE TO REMOVE THE SAFETY WIRE TO ALLOW FULL DEPLOYMENT - WIRE BROKE OFF AT END UNDER EXTREME TENSION, GREEN WIRE NOTED CAUGHT AROUND STENT ( SOMETHING THEY HAVE NEVER SEEN BEFORE) THEY WERE UNABLE TO DETACH STENT FROM DEPLOYMENT DEVICE - ULTIMATELY REMOVING STENT AND DEPLOYMENT SYSTEM OUT OF PATIENT AND THROUGH ENDOSCOPE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8183548 ↗