Evolution G23127Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002231273), received between Mar 1, 2016 and Aug 7, 2026 — classified as 2 injuries, 10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170780 ↗
• MalfunctionJul 31, 2025Migration; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672756 ↗
• MalfunctionJun 28, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-NOV-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631371 ↗
• MalfunctionNov 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-FEB-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082229 ↗
• MalfunctionNov 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN ERCP PERFORMED BY (B)(6) DR., WHEN RELEASING THE PROSTHESIS, WHEN THE DOCTOR PULLED THE TRIGGER, THE METAL ROD CAME OUT, WITHOUT HAVING PUSHED AND RELEASED THE PROSTHESIS... THE DOCTOR HAD TO REPLACE THIS DEFECTIVE PROSTHESIS WITH ANOTHER, WHICH LENGTHENED THE INTERVENTION TIME. FURTHERMORE, THE METAL ROD THAT CAME OUT OF THE GUIDE COULD HAVE DAMAGED THE ENDOSCOPE SHEATH. "AS PER CC FORM": PLACEMENT OF A BILIARY STENT. WHEN THE NURSE ACTIVATED THE DELIVERY SYSTEM TRIGGER. A METAL ROD COMES OUT OF THE CARRIER CATHETER. THE PROSTHESIS DID NOT COME OUT. REMOVAL OF THE DEVICE. USE OF AN UNCOVERED BOSTON 4 CM STENT. (EMDR 3001845648-2023-00771) QUESTIONS RELATED TO DURING INSERTION INTO PATIENT 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO THIS FILE WILL CAPTURE USER ERROR OF THE CUSTOMER NOT INSPECTING THE DEVICE FOR DAMAGE BEFORE USE. 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 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHEN UNPACKING O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046841 ↗
• MalfunctionOct 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 17-OCT-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895646 ↗
• MalfunctionFeb 16, 2023Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385815 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA VERBAL COMMUNICATION WITH THE DISTRICT MANAGER: TWO TO THREE DAYS AFTER THE PATIENT UNDERWENT AN ERCP PROCEDURE IN WHICH THE EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED, G23127, WAS USED, THE PATIENT HAD BILIARY SEPSIS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? PT 1: HOSPITALIZED DUE TO OBSTRUCTIVE JAUNDICE AND UNDERWENT ERCP AS AN INPT; HE REMAINED HOSPITALIZED UNTIL HIS DEATH. BECAME HYPOTENSIVE EVENING AFTER STENT PLACEMENT, TRANSFERRED TO ICU, CT OBTAINED (MOVIE ATTACHED), BUT WAS UNSTABLE TO UNDERGO EMERGENCY ERCP. BY THE TIME HE WAS STABILIZED, FAMILY OPTED FOR HOSPICE PATIENT OUTCOME: 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? PT 1: HOSPITALIZED DUE TO OBSTRUCTIVE JAUNDICE AND UNDERWENT ERCP AS AN INPT; HE REMAINED HOSPITALIZED UNTIL HIS DEATH. BECAME HYPOTENSIVE EVENING AFTER STENT PLACEMENT, TRANSFERRED TO ICU, CT OBTAINED (MOVIE ATTACHED

  Patient problems: Occlusion; Sepsis

  MAUDE report 10066330 ↗
• InjuryApr 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED 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 2-3 DAYS POST PROCEDURE. THE PATIENT WAS HOSPITALIZED DUE TO OBSTRUCTIVE JAUNDICE AND UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) AS AN IN PATIENT; HE REMAINED HOSPITALIZED UNTIL HIS DEATH. BECAME HYPOTENSIVE EVENING AFTER STENT PLACEMENT, TRANSFERRED TO ICU, CT OBTAINED, BUT WAS UNSTABLE TO UNDERGO EMERGENCY ERCP. BY THE TIME HE WAS STABILIZED, FAMILY OPTED FOR HOSPICE. FURTHERMORE, PATIENT WAS NOT STABLE ENOUGH TO UNDERGO EMERGENCY ECRP ON INITIAL TRANSFER TO ICU AND WAS PLACED ON HOSPICE THE FOLLOWING MORNING.

  Patient problems: Sepsis

  MAUDE report 10010090 ↗
• MalfunctionJan 17, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  STENT DID NOT FULLY DEPLOY AND THE DEPLOYMENT MECHANISM APPEARED TO SNAP AND THEN A CLICKING WAS HEARD. THE SCOPE WAS NOT IN A TORTUOUS POSITION AND THE CATHETER WAS STRAIGHT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9601398 ↗
• MalfunctionNov 20, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE REASON FOR REPORTING IN THE COMPLAINT DESCRIPTION WHICH HAS CHANGED SINCE THE LAST REPORT. THEY HAD AN ISSUE WITH THEIR EVOLUTION BILIARY STENT G23127 LOT C1588832. DURING AN ERCP WITH DR. (B)(6), THE EVOLUTION BILIARY STENT WOULD NOT DEPLOY. THE PROCEDURE CONTINUED BY ANOTHER STENT AND COMPLETED. PROCEDURE DATE UNKNOWN. FDA MDR REPORTING REQUIRED: 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 EXPOSED STENT REMOVED FROM PATIENT WITH DELIVERY SYSTEM' . NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9350997 ↗
• MalfunctionMar 1, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: WHEN THE USER WAS INITIALLY DEPLOYING THE EVOLUTION BILIARY STENT, THE NURSE PULLED THE SAFETY WIRE FROM THE DEVICE (AT BEGINNING OF PROCEDURE). THE STENT DEPLOYED FINE BUT WHEN THE PHYSICIAN WANTED TO RETRACT FOR REPOSITIONING, THE STENT WOULD NOT RETRACT. THEY REMOVED THE STENT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A NEW STENT. THE STAFF HAS SINCE BEEN RE-INSERVICED ON THE DEVICE. EVENT MEETS FDA MDR REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR 'A DEPLOYMENT ISSUE RESULTING IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5469631 ↗