Evolution G48029Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002480299), received between May 11, 2016 and Sep 25, 2025 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 25, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  WHILE PUSHING THE STENT INTO COLON THE INNER CATHETER BECAME LONGER THAN THE STENT AND DOCTOR ARGUE HE COULDN'T ADVANCE IT DUE TO THIS EVENT; THEN HE TOOK ANOTHER COOK STENT AND FINISHED THE PROCEDURE. "AS PER CC FORM": TUMOR IN SIGMA AREA, DOCTOR PUSHED THE STENT BUT COULDN'T ADVANCE IT THROUGH THE STENOSIS AND HE PULLED OUT TO SEE WHAT WAS GOING ON AND HE FOUND THE EXTERNAL CATHETER HAD STRETCHED (SEE PICTURE ATTACHED) AND HE HAD TO USED ANOTHER ONE. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT YES, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCE, DURING STENT REPOSITIONING/REMOVAL. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? FUJIFILM EC-760R-V/L 3.8 WHAT WAS THE POSITION OF THE ELEVATOR? (WAS IT OPENED OR CLOSED?) COLONOSCOPE DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0035¿ JAGWIRE BOSTON DID ANY PART OF THE STENT CONTACT THE PATIENT'S ANATOMY WHEN THE COMPLAINT OCCURRED? YES HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? N/A FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23149516 ↗
• MalfunctionApr 16, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848904 ↗
• MalfunctionOct 30, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DURING ENDOSCOPIC STENT PLACEMENT FOR COLONIC STENOSIS, USER CANNOT ADVANCE THE STENT DELIVERY SYSTEM ALONG WITH WIRE GUIDE TO COLON STENOSIS , THEN RETRACTED THE DELIVERY SYSTEM , AND AGAIN ADVANCED THE WIRE GUIDE TO STENOSIS AREA SO THAT THE STENT DELIVERY SYSTEM CAN BE ADVANCED THROUGH WIRE GUIDE WHILE FOUND OUT THE TIP OF STENT BENT AND DEFORMED WHICH CAUSE THE WIRE GUIDE CANNOT BE PUT THROUGH. USER CHANGED TO A NEW 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. FOR ALL COMPLAINTS, ASK: 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? METII-35-480, COOK METII-35-480. 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH A NEW ONE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: 3. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS CF-HQ290I. CF-HQ290I. HAD DILATION OF THE STRICTURE BEEN PERFORMED PRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566175 ↗
• DeathAug 30, 2018Mechanical Problem; Mechanical Problem

  STENT WAS IMPLANTED AND 4 DAYS LATER, A PERFORATION OF COLON WAS FOUND. PATIENT DIED. "AS PER COMPLAINT FORM": STENT PLACED WITHOUT ANY ISSUES. FOUR DAYS LATER, A PERFORATION IN THE COLON OCCURRED; PATIENT PASSED AWAY. I AM WAITING FOR MORE DETAILED INFO FROM DR (B)(6), WHICH WILL BE FORWARDED AS SOON AS I RECEIVED THEM.

  Patient problems: Bowel Perforation; Death

  MAUDE report 7831695 ↗
• MalfunctionMay 2, 2018Kinked; Kinked

  PRODUCT FAILED/MALFUNCTION .LOGGED AGAINST LAST LOT SENT FOR THIS REF. "AS PER COMPLAINT FORM": DOCTOR DESCRIBED AFTER ADVANCING THE STENT CATHETER TO THE DESIRE PLACE, THEY BEGIN TO RELEASE THE STENT BY SQUEEZING THE TRIGGER OF THE HANDLE BUT THEY REALIZE THAT EVEN THE TRIGGER WAS PUSH THE STENT ITSELF WAS NOT DEPLOYING AT ALL. THEY RECAPTURE AND TRIED TWO MORE TIMES BUT IT DIDN'T WORK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479319 ↗
• InjuryOct 24, 2017Material Separation; Improper or Incorrect Procedure or Method; Delivery System Failure; Material Separation; Improper or Incorrect Procedure or Method; Delivery System Failure

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE COMPLAINT DEVICE BEING RETURNED AND DEVICE EVALUATION. AS REPORTED TO CUSTOMER RELATIONS: "DURING A COLONOSCOPY PROCEDURE THE PHYSICIAN DID NOT USE THE WIRE GUIDE. THE PROCEDURE WAS TO PLACE AN EVOLUTION STENT IN THE SIGMOID COLON. THE PHYSICIAN DEPLOYED THE STENT AND WHEN DEPLOYED IT TURNED IN ON ITSELF AT THAT POINT, THE STAFF NOTED THAT THE WHITE TIP AND PART OF THE INTRODUCTION SYSTEM HAD DETACHED FROM THE CATHETER. THE PHYSICIAN REMOVED THE DETACHED PORTION OF THE DEVICE AND THE STENT BY HAND. THE PHYSICIAN USED A COLONOSCOPE DURING THE PROCEDURE." (EDITED BY AR 27SPET2017 PER PHONE CONVERSATION WITH DM). PER DM, "WHEN THEY DEPLOYED THE STENT, THAT ONE SIDE OF THE STENT WOULD NOT OPEN; WAS COMPRESSED." THE DM REACHED OUT TO THE PHYSICIAN REGARDING SCHEDULING AN IN-SERVICE ON THE COMPLIANT DEVICE AND WILL SCHEDULE AN IN-SERVICE WITH STAFF. AR 27SEPT2017. THE DISTRICT MANAGER IS TO CONFIRM FURTHER DETAILS OF THE EVENT AND WILL SCHEDULE AN INSERVICE WITH THE PHYSICIAN AND STAFF. TH 27SEPT2017.

  Patient problems: Foreign Body In Patient

  MAUDE report 6971082 ↗
• InjuryMay 11, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER THOUGHT THEY DEPLOYED AN EVOLUTION COLONIC STENT 100%. HANDLE INDICATOR WAS COMPLETELY AT THE END BUT THE STENT WAS NOT VISIBLE ON X RAY. DEVICE WAS REMOVED BUT THE STENT WAS NOT IN THE INTRODUCTION SYSTEM. THE EVOLUTION COLONIC STENT WAS STUCK IN THE ACCESSORY CHANNEL OF THE SCOPE. FDA MDR REPORTING REQUIRED BASED ON A MALFUNCTION REPORTING PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5646708 ↗