Evolution G48033Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002480336), received between Apr 12, 2016 and Apr 6, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Physical Resistance/Sticking

  THE STENT ABRUPTLY OPENED AND COULD NOT BE RETRIEVED BACK. THE PROCEDURE WAS COMPLETED BY COMPETITOR DEVICE. WHAT WAS THE TARGET LOCATION? ESOPHGEAL. WHAT WAS THE DIAMETER OF THE WIRE GUIDE USED? 0.035X480 CMS. 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? NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO. WAS PRE-DILATION/POST-DILATION PERFORMED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792624 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 29 MAY 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20985887 ↗
• MalfunctionApr 24, 2024Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  THE STENT COULD NOT BE DEPLOYED, AS THE TRIGGER GOT JAMMED. PATIENT/EVENT INFO - NOTES: QUERY REPLY: 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] ¿ DURING STENT PLACEMENT. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? 3. WHAT WAS THE POSITION OF THE ELEVATOR? [N/A, OPEN, CLOSED]. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035 INCH ¿ SGW GUIDE WIRE 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? [N/A, YES, NO]. 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? [YES]. 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. ESOPHAGUS. 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? THE CUSTOMER COULD NOT RECALL THE TIME, BUT SAID MINIMAL TIME. 9. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETED? [N/A]. 10. IF YES, HOW OFTEN WAS THIS COMPLETED? 11. DID THE PATIENT R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173182 ↗
• MalfunctionJun 9, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 06-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096986 ↗
• InjuryMay 2, 2023Migration; Migration

  MDR- 2054 106-007 AE1. MDR- 2054 106-007 AE1 - GASTROINTESTINAL: OTHER ; STENT DISLOCATION DISTAL, RELATIONSHIP: DEVICE , RELATED ; STENT DISLOCATION NEEDS TO REPOSITION, PROCEDURE: NON RELATED, PRE-EXISTING,: NO , DEFICIENCY: NO. 2 DAYS POST PROCEDURE. STENT DISLOCATION DISTAL - STENT REPOSITIONED ENDOSCOPICALLY. STATUS: RESOLVED, TREATMENT: ENDOSCOPIC, STUDY STENT REPOSITIONED, DEATH: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 16852579 ↗
• MalfunctionSep 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348054 ↗
• InjuryAug 15, 2022Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DOCTOR WAS DEPLOYING 15CM ESOPHAGEAL EVOLUTION PARTIALLY COVERED METAL STENT,AFTER DEPLOYMENT WHEN DOCTOR PULLED THE DELIVERY DEVICE THE PROXIMAL PART OF THE STENT BEND INSIDE THE STENT.DOCTOR REMOVED THE STENT WITH THE HELP OF THE RAT TOOTH FORCEP AND DEPLOYED ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224371 ↗
• MalfunctionJan 14, 2022Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure

  AS PER SOURCE DOC: "CUSTOMER INDICATED THAT THEY COULDN'T PLACE THE PRODUCT".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257073 ↗
• MalfunctionMay 12, 2021Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812799 ↗
• MalfunctionFeb 5, 2021Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or 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 11284883 ↗
• MalfunctionJun 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ISSUES WITH A ESOPHAGEAL STENT. SURGEON WANTED A 20 FR STENT WHICH THEY TOOK FROM THE ENDOSCOPY UNIT DOWNSTAIRS. THE SURGEON HAD NEVER USED THE COOK STENTS BUT HE SAID WAS FAMILIAR WITH THE BOSTON SCIENTIFIC ONES. WHILE HE WAS DEPLOYING IT HE DID EXPERIENCE SOME DIFFICULTY TOWARDS THE LAST PART OF IT BUT THEN HE THOUGHT ¿.MAY BE THAT¿S HOW IT IS AND THEN WHILE HE WAS PULLING IT BACK THE WHOLE STENT ALSO CAME ALONG WITH IT AND COULD NOT BE USED ANYMORE. THE RELEASE PIN WAS NOT PULLED BEFORE CATHETER REMOVAL. PATIENT OUTCOME: DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED (IF APPLICABLE): DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. PLEASE SPECIFY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: DID THE COMPLAINANT INFORM OF ANY ADVERSE EFFECT(S) ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE COMPLAINANT INFORM THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECT(S)? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137288 ↗
• MalfunctionJan 29, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  EVENT DESCRIBED BY DR.(B)(6) ,AFTER PLACING AN .035 STIFF WIRE THROUGH THE SCOPE ,UNDER FLORO , THE STENT WAS ADVANCED ON THE STIFF GUIDE WIRE, AFTER POSITIONING IT WELL , THEY STARTED TO DEPLOY THE STENT , UNFORTUNATELY THEY COULD NOT SEE THE STENT OPENING UNDER XRAY, THE RED VISUAL MARKER ON THE TOP OF THE HANDLE WAS COMING BACKWARD , BUT EVEN AFTER IT REACHES POINT OF NO RETURN THE PROXIMAL END OF THE STENT WAS NOT OPENING , THE METAL STYLET WAS REMOVED BUT STILL THEY COULD NOT DEPLOY THE STENTS , THE WHOLE ASSEMBLY WAS TAKEN OUT OF THE PATIENT , EVEN IN THE AIR THE STENT WAS NOT OPENING . THE PROCEDURE WAS COMPLETED USING OTHER COMPANY STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9642838 ↗
• InjuryJun 4, 2019Difficult to Remove; Difficult to Remove

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: PER DISTRIBUTORS EMAIL: OUR QA STAFF REPORTED THE FOLLOWING CASE: DOCTORS WERE PERFORMING AN ESOPHAGEAL STRICTURE. THE DOCTOR INSERTED THE STENT AND ONCE READY FOR RELEASE INSIDE THE PATIENT THE SECURE DID NOT COME OUT, THE STENT STARTED TO EXPAND INTO THE PATIENT BUT IT COULD NOT BE RELEASED BECAUSE OF THE STUCKED SAFE CAUSING AN ESOPHAGEAL TEARING. PER THE CUSTOMERS COMPLAINT FORM: AT THE MOMENT OF THE INTRODUCTION AND PROCEEDING WITH THE RELEASED OF THE STENT, IT COULDNT BE RELEASED BECAUSE OF THE SAFE. THE DOCTOR DECIDES TO TAKE THE STENT AWAY CAUSING ESOPHAGEAL TEARING.

  Patient problems: Excessive Tear Production

  MAUDE report 8665885 ↗
• MalfunctionFeb 13, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AFTER PULLING OUT THE WIRE TO FINALLY PLACE THE STENT, THE STENT COULD NOT BE PLACED IN THE STRICTURE. HENCE THE ENTIRE SYSTEM HAD TO BE PULLED OUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7266087 ↗
• MalfunctionNov 29, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. STENT WAS BEING DEPLOYED, THEN WAS RETRACTED TO REPOSITION. STENT WOULD NOT RETRACT PROPERLY WITH SOME OF THE STENT BEING VISIBLE AFTER RETRACTION. ENDOSCOPE AND STENT REMOVED FROM PATIENT AS PROCEDURE COULD NOT CONTINUE WITH COOK STENT. ENDOSCOPE INSERTED BACK INTO PATIENT AND A NEW STENT FROM ANOTHER SUPPLIER WAS USED TO COMPLETE PROCEDURE. A MALFUNCTION PRECEDENCE EXISTS FOR A DEPLOYMENT ISSUE THAT RESULTS IN AN EXPOSED STENT BEING REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6131639 ↗
• InjurySep 12, 2016Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  THE USER ATTEMPTED TO PLACE EVO-20-25-15-E INSIDE AN 8CM BARE STENT PREVIOUSLY PLACED IN THE ESOPHAGUS. HE ALIGNED THE DISTAL END OF THE EVO STENT AT THE DISTAL END OF THE 8CM BARE STENT, AND DEPLOYED THE STENT AS EXTENDING TO THE PROXIMAL SIDE. HOWEVER, IT WAS 'STENT-IN-STENT', SO THE EVO STENT WAS NOT APPRESSED TO THE ESOPHAGUS WALL. THE EVO STENT MIGRATED TO THE PROXIMAL SIDE BECAUSE THE DELIVERY SYSTEM TIP CAUGHT THE EVO STENT DURING REMOVAL. STENTING BECAME LONGER THAN THE USER PLANNED, SO HE REMOVED THE EVO STENT USING A GRASPING FORCEPS AND PLACED A 12.5CM STENT SUCCESSFULLY TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5942546 ↗
• MalfunctionAug 24, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INFORMATION INITIALLY RECEIVED INDICATED THE EVOLUTION STENT FAILED TO DEPLOY. NOTE THE STENT WAS RETURNED FULLY DEPLOYED WITH DISPLACED LASSO LOOPS. ADDITIONAL INFORMATION RELATING TO THIS COMPLAINT HAS BEEN REQUESTED BUT TO DATE CLARIFICATION HAS NOT BEEN RECEIVED. FDA MDR REPORTABLE BASED UPON A REPORTING PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5899593 ↗
• MalfunctionMay 11, 2016Fracture; Fracture

  DR. SHOWED ME A VIDEO OF A ENDOSCOPY WHERE A PIECE (~ 3CMS) OF THE EVOLUTION DISTAL END (OF THE STENT) WAS TOTALLY BROKEN, THIS MEAN IN TWO PIECES ONE PART IMPLANTED AND THE OTHER IN THE STOMACH. PATIENT RETURNED WITH APHAGIA - THAT IS WHEN THEY CONFIRMED THE ISSUE. A NEW DEVICE WAS IMPLANTED TO RECTIFY THE ISSUE. THE STENT HAD BEEN IMPLANTED IN THE PATIENT FOR 3 YEARS PRIOR TO THIS OCCURRENCE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5646580 ↗
• MalfunctionApr 12, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE EVOLUTION STENT COULDN'T BE RELEASED - EVEN WITH THE SAFETY WIRE PULLED. WHEN THE USER REMOVED THE INTRODUCER THE FULLY EXPANDED STENT WAS ALSO REMOVED OUT OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5570344 ↗