Evolution G48031Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002480312), received between Feb 29, 2016 and Jul 30, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50080062 ↗
• MalfunctionDec 19, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  THE STENT DID NOT COME OUT OF THE CATHETER, THE TRIGGER MECHANISM GOT JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976110 ↗
• MalfunctionApr 3, 2024Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  THE STENT OPENED PREMATURELY AND COMPLETELY IN THE WRONG POSITION, EVEN THOUGH THE MARKING ONLY REACHED HALFWAY ALONG THE SCALE WHEN IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031866 ↗
• MalfunctionFeb 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE ISSUE: INADEQUATE STENT EXPANSION. RELATIONSHIP QUESTIONS STUDY DEVICE: BLANK, PROCEDURE: NOT RELATED. PRE-EXISTING: BLANK. DEVICE DEFICIENCY: BLANK AS PER ATTACHED PATIENT CASEBOOK, " 1. DATE OF PROCEDURE: (B)(6) 2018. 2. REASON FOR STENT PLACEMENT: MALIGNANT OBSTRUCTION (EXTRINSIC). 3. MORPHOLOGY OF STUDY LESION: LENGTH OF STUDY LESION: 8 (CM); DIAMETER OF ESOPHAGUS AT THE LOCATION OF THE STUDY LESION 9 (MM) ". "POST-PROCEDURAL INFORMATION: 4. WAS TUMOR-REDUCTION THERAPY DOCUMENTED DURING FOLLOW UP? NO. 5. WERE THERE ANY MEDICAL PROBLEMS OR COMPLICATIONS DOCUMENTED AFTER THE STUDY PROCEDURE AND THROUGH FOLLOW-UP MEDICAL RECORD REVIEW? NO. 6. WERE ANY DEVICE DEFICIENCIES DOCUMENTED AFTER THE STUDY PROCEDURE AND THROUGH FOLLOW-UP MEDICAL RECORD REVIEW; INCLUDING DEVICE DEFICIENCIES THAT MAY HAVE OCCURRED DURING STENT REPOSITIONING OR REMOVAL? NO".. "2. ADVERSE EVENT ONSET (DAYS POST STENT PLACEMENT): 26 7. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? YES. 8. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? NO. 3. EVENT CATEGORY (SELECT ONLY ONE EVENT PER FORM): DEVICE ISSUES -- INADEQUATE STENT EXPANSION. 4. EVENT TREATMENT: ENDOSCOPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18795537 ↗
• InjuryNov 9, 2023Improper or Incorrect Procedure or Method; Structural Problem; Improper or Incorrect Procedure or Method; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 09-FEB-2024.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18099898 ↗
• MalfunctionMar 29, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  WHILE DOING STENTING CASE STENT OPENED AND SAFETY WIRE CANT ABLE TO REMOVE. LAB EVALUATION 28TH SEP 2022. VISUAL INSPECTION. LOCK WIRE STILL IN PLACE . RED MARKER PASSED POINT OF NO RETURN.. FUNCTIONAL INSPECTION. ACTUATING AS INTENDED. PIGTAIL LOCK WIRE REMOVED WITH SLIGHT DIFFICULTY. STENT DEPLOYED FULLY. PATIENT/EVENT INFO - NOTES: QUERY REPLY: 1. WHILE INSERTING STENT, 2. ITS OVER THE WIRE DEVICES NOT THROUGH THE SCOPE, 3. NA, 4. 0.35, 5. YES, 6. NO, 7. LOWER ESOPHAGUS, 8. NA, 9. NO, 10. NO, 11. NO, 12. ANOTHER STENTING, 13. NO, 14. YES, 15. STENT NOT OPENED. STRICTURE INFORMATION , 1. LENGTH 4CM, 2. LOWER ESOPHAGUS, 3. NO, 4. NO, 5. YES. DURING STENT PLACEMENT , 1. NO, 2. WHILE DEPLOYING STENT NOT OPENED , 3. NO, 4. NO, 5. YES, 6. YES. 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? 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)? 5. WAS THE ZIP PORT FACING UPWARDS AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636123 ↗
• MalfunctionAug 11, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  FAILURE TO PLACE INDICATED ON THIS LOT AS PER CC FORM RECEIVED 27-JUL-2022: "ECHEC DE POSE : THE DOCTOR DIDN'T CHOOSE THE GOOD SIZE. NO MORE DETAILS." 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209853 ↗
• MalfunctionDec 10, 2021Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  PAEDIATRIC OLYMPUS GASTROSCOPE PASSED BEYOND THE STRICTURE AND PLACED SAVARY GUIDEWIRE AND EXTERNAL MARKERS PLACED USING FLUOROSCOPE . OVER THE PRE-POSITIONED GUIDEWIRE ,PASSED THE 10 CM PARTIALLY COVERED EVOLUTION OESOPHAGEAL DELIVERY DEVICE AFTER FLUSHING THE GUIDEWIRE PORT WITH DISTILLED WATER AND LUBRICATED WITH XYLOCAINE JELLY FOR SMOOTH PASSAGE OF DELIVERY AND CROSSED BEYOND THE STRICTURE AND TRIED TO DEPLOY THE STENT. AFTER THREE SQUEEZES THE TRIGGERING WAS VERY DIFFICULT TO SQUEEZE,TRIED TO RECAPTURE ,POSITIONED BACK TO ORIGINAL POSITION AND AGAIN PRESSED THE DEPLOYMENT BUTTON AND TRIED TO DEPLOY ,THREE SQUEEZES WENT WELL AGAIN FELT HARDER TO DEPLOY ,THE STYLES TRIED TO CAME OUT OF THE UPPPER PART OF THE HANDLE ,REMOVED DELIVERY DEVICE FROM THE PATIENTS BODY,TRIED OUTSIDE TO DEPLOY ,VERY DIFFICULT TO SQUEEZE,FOUND MALFUNCTION OF HANDLE,NOT ABLE TO DEPLOY THE 10CM STENT. IMMEDIATELY TAKEN 12.5CM EVOLUTION STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974260 ↗
• MalfunctionMay 7, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS INSTRUCTED BY THE MANUFACTURE "USER ERROR- AFTER THE SAFETY WIRE REMOVAL, THE PHYSICIAN STILL TRIED TO RECAPTURE THE STENT." AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789378 ↗
• InjuryDec 4, 2020Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  AS REPORTED BY THE INITIAL REPORTER, "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10945526 ↗
• InjuryDec 2, 2020Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON (B)(6)2021. AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED." DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. · PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO. · PLEASE SPEC

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

  MAUDE report 10936565 ↗
• MalfunctionNov 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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 10893851 ↗
• MalfunctionApr 8, 2020Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  THE STENT COULD NOT BE RELEASED. "AS PER COMPLAINT FORM": PHYSICIAN TRIED TO DEPLOY THE STENT RIGHT AFTER THE ASSISTANCE PULLED RELEASED THE RELEASE-STILETTE. THE STENT COULD NOT BE RELEASED FROM THE SYSTEM ALTHOUGH THEY TRIED TO FORCE THE RELEASE WITH AN ADDITIONAL FORCEPS. AFTER SEVERAL TRIES THE STENT WAS PULLED OUT OF THE PATIENT AND THEY USED DIFFERENT ONE FROM MICROTECH. 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 problems: No Known Impact Or Consequence To Patient

  MAUDE report 9939119 ↗
• MalfunctionFeb 24, 2020Difficult or Delayed Activation; Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Difficult or Delayed Activation; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  STENT DEPLOYED SUCCESSFULLY BUT STENT CAME OUT WITH INTRODUCER EVEN THOUGH REMOVAL PIN REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9744845 ↗
• MalfunctionOct 3, 2019Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  THE WHITE GOT DETACHED FROM CATHETER. "AS PER COMPLAINT FORM": THE WHITE INNER CATHETER-TIP GOT DETACHED FROM CATHETER.

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

  MAUDE report 9149703 ↗
• MalfunctionNov 29, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT NOT EXPANDING/OPENING POST DEPLOYMENT". AS REPORTED TO CUSTOMER RELATIONS: "PHYSICIAN IS WELL-VERSED IN PLACING. MEASURED STRICTURE, CHOSE SIZE. PLACEMENT OF STENT WENT SMOOTHLY, EXCEPT ON THE PROXIMAL END THE STENT WOULD NOT OPEN. APPEARED TO HAVE A TANGLED LASSO LOOP, PER PHYSICIAN. PHYSICIAN DETERMINED TO USE ANOTHER STENT OVER SAME LOCATION, PERFORMED THIS WITHOUT ISSUE. PATIENT WAS FINE, NO ADVERSE EFFECTS. 2ND DEVICE WAS ANOTHER COOK STENT, UNKNOWN BEYOND THAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115680 ↗
• MalfunctionOct 1, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER ADVANCED THE DELIVERY SYSTEM OVER A WIRE GUIDE AND RELEASED THE WHOLE STENT AT THE TARGET SITE IN THE ESOPHAGUS WITHOUT NOTABLE RESISTANCE, AND THEN HE REMOVED THE SAFETY WIRE. HOWEVER THE PROXIMAL SIDE OF THE STENT WOULD NOT EXPAND. HE ATTEMPTED TO EXPAND IT BY POKING WITH FORCEPS BUT IT STILL DIDN'T EXPAND. HE GRASPED THE STENT USING FORCEPS AND REMOVED FROM THE PATIENT AND SUCCESSFULLY PLACED EVO-20-25-12.5-E INSTEAD TO COMPLETE THE PROCEDURE. WHEN THE USER CHECKED THE STENT AFTER THE PROCEDURE, THE PROXIMAL SIDE OF THE STENT EXPANDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922497 ↗
• InjuryMar 22, 2018Detachment Of Device Component; Material Separation; Delivery System Failure; Detachment Of Device Component; Material Separation; Delivery System Failure

  MALFUNCTIONED EVOLUTION STENT. ADDITIONAL INFORMATION RECEIVED 2ND MAR 2018 DW THE TIP OF THE INTRODUCER (THE TULIP) CAME OFF IN THE PATIENT WHILE DEPLOYING THE STENT. THEY FINISHED THE CASE WITH A SECOND STENT.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7361552 ↗
• MalfunctionNov 16, 2016Positioning Failure; Positioning Failure

  THE TRIGGER WAS FIRED TO THE END AND THE SECURITY THREAD WAS REMOVED AS PER INSTRUCTIONS FOR USE. THE PROSTHESIS WAS IN THE DESIRED LOCATION FOR RELEASE AND OPENING NORMALLY. WHEN REMOVING THE DEVICE THE PROSTHESIS DOES NOT DETACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105265 ↗
• MalfunctionJul 20, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AFTER PLACEMENT OF THE WIRE GUIDE INTO THE STOMACH WITHOUT PROBLEM, THE ENDOSCOPE IS NOW OUT AND THE USER STARTED TO DEPLOY THE EVOLUTION STENT WITH NO ISSUES. THE SAFETY WIRE (AT THE POINT OF NO RETURN) WAS PULLED OUT BUT NOT FULLY (15 CM). THE DISTAL PART OF THE STENT IS DEPLOYED BUT THE PROXIMAL PART OF THE STENT DID NOT LOOK LIKE IT DEPLOYED WELL. THE DOCTOR DECIDED TO REMOVE THE WHOLE SYSTEM. OUT OF THE BODY, THEY SAW THAT THE STENT WAS STILL FIXED TO THE CATHETER. THE DOCTOR LEFT THE WIRE GUIDE IN THE PATIENT AND PLACED ANOTHER EVO-20-25-10-E WITH SUCCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5807981 ↗
• InjuryApr 11, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS PROCEDURE WAS THE FIRST CASE FOR THIS USER TO USE EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED. HE PLACED THE STENT AT THE TARGET SITE BUT IT MIGRATED INTO THE STOMACH. HE REMOVED THE MIGRATED STENT USING TUBE/CATHETER THROUGH THE MOUTH AND PLACED ANOTHER EVOLUTIONESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED AT THE TARGET SITE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5566783 ↗
• MalfunctionFeb 29, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PROCEDURE TO PLACE THE EVO BILIARY STENT WENT SMOOTHLY UNTIL THE TIME CAME TO REMOVE THE INTRODUCTION SYSTEM. THE USER NOTED VIA FLUOROSCOPY THAT THE STENT WAS MOVING ALSO WHEN THE INTRODUCTION SYSTEM WAS BEEN WITHDRAWN. THE USER ENDED UP REMOVING THE WHOLE SYSTEM (INTRODUCTION SYSTEM AND STENT) FROM THE PATIENT. EVENT MEETS 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 5467397 ↗