EvolutionRecalls & reported problems across all models

We found 21 models of Evolution by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 458 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2016 and Sep 29, 2026 — classified as 2 deaths, 108 injuries, 348 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (157 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Evolution problems

Evolution models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evolution G23128

  CATHETER, BILIARY, DIAGNOSTIC
  72 reports
• Evolution G48026

  STENT,METALLIC,EXPANDABLE,DUODENAL
  1 death57 reports
• Evolution G48028

  STENT, COLONIC, METALIC, EXPANDABLE
  45 reports
• Evolution G48038

  STENT, COLONIC, METALIC, EXPANDABLE
  45 reports
• Evolution G23129

  CATHETER, BILIARY, DIAGNOSTIC
  41 reports
• Evolution G48032

  PROSTHESIS, ESOPHAGEAL
  32 reports
• Evolution G48027

  STENT,METALLIC,EXPANDABLE,DUODENAL
  30 reports
• Evolution G48031

  PROSTHESIS, ESOPHAGEAL
  22 reports
• Evolution G23130

  CATHETER, BILIARY, DIAGNOSTIC
  19 reports
• Evolution G48033

  PROSTHESIS, ESOPHAGEAL
  19 reports
• Evolution G48030

  PROSTHESIS, ESOPHAGEAL
  16 reports
• Evolution G48025

  STENT,METALLIC,EXPANDABLE,DUODENAL
  14 reports
• Evolution G23127

  CATHETER, BILIARY, DIAGNOSTIC
  12 reports
• Evolution G23126

  CATHETER, BILIARY, DIAGNOSTIC
  7 reports
• Evolution G48029

  STENT, COLONIC, METALIC, EXPANDABLE
  1 death7 reports
• Evolution G52227

  PROSTHESIS, ESOPHAGEAL
  6 reports
• Evolution G52226

  PROSTHESIS, ESOPHAGEAL
  5 reports
• Evolution G52225

  PROSTHESIS, ESOPHAGEAL
  4 reports
• Evolution G23124

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• Evolution G51183

  PROSTHESIS, ESOPHAGEAL
  2 reports
• Evolution G51182

  PROSTHESIS, ESOPHAGEAL
  1 report

Recent Evolution adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933427 ↗
• MalfunctionSep 24, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890293 ↗
• InjurySep 21, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50846472 ↗
• MalfunctionAug 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205892 ↗
• MalfunctionAug 7, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170780 ↗
• MalfunctionJul 30, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50080062 ↗
• MalfunctionJul 16, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25836380 ↗
• MalfunctionJun 10, 2026Activation Failure

  THE STENT DELIVERY SYSTEM PASSED THROUGH THE ENDOSCOPIC WORKING CHANNEL AND REACHED THE LOCATION OF THE OBSTRUCTION IN THE SIGMOID COLON. USER ADVANCED SYSTEM THE STENOSIS AND RELEASED THE STENT. HOWEVER, IT WAS FOUND THAT THE STENT COULD NOT BE RELEASED. THE SAFETY WIRE WAS REMOVED, BUT THE STENT STILL COULD NOT BE RELEASED. SUBSEQUENTLY, IT WAS WITHDRAWN FROM THE BODY AND REPLACED WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462114 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  AFTER THE NURSE OPENED THE PACKAGE, THE STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE ENDOSCOPE AND POSITIONED IN THE COMMON BILE DUCT. WHEN THE OPERATOR ATTEMPTED TO DEPLOY THE STENT, A CRACK WAS NOTED IN THE DELIVERY-SYSTEM HANDLE; MANIPULATING THE TRIGGER WAS DIFFICULT AND INTERFERED WITH OPERATION. THE DEVICE WAS RETRACTED, A NEW LIKE STENT WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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? - STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? - OLYMPUS JF260V. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? - CLOSED. WHAT WAS THE TARGET LOCATION? - COMMON BILE DUCT. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? - METII-35-480. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? - YES. DID ANY PART OF THE STENT CONTACT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237393 ↗
• MalfunctionMay 18, 2026Deformation Due to Compressive Stress; Activation Failure

  UNABLE TO RETRIEVE THE PROSTHESIS FROM THE WEARER. PROBLEM ENCOUNTERED WHEN RELEASING THE PROSTHESIS; IMPOSSIBLE TO RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207387 ↗
• MalfunctionMay 12, 2026Material Deformation; Material Twisted/Bent

  UPON NORMAL OPENING OF THE PACKAGE, THE STENT WAS INTRODUCED ALONG THE WIRE GUIDE. HOWEVER, UPON REACHING THE STENOSIS AREA, RESISTANCE WAS ENCOUNTERED JUST AS IT WAS ABOUT TO REACH THE TURNING POINT, MAKING IT DIFFICULT TO ADVANCE THE STENT DELIVERY SYSTEM. AFTER SEVERAL ATTEMPTS, IT WAS UNSUCCESSFUL. UPON RETRACTION OF THE STENT DELIVERY SYSTEM, TWO KINKS WERE OBSERVED ON THE STENT SHEATH. CONCERNED ABOUT POTENTIAL ACCIDENTS IF THE STENT WAS CONTINUED TO BE USED, A NEW STENT WAS SUBSTITUTED 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. ARE THERE ANY CLINICAL IMAGING/VIDEOS AVAILABLE? NO. WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? (KINKS ETC) NO. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035'' WIRE GUIDE. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO. WAS AN ASSESSMENT CARRIED OUT TO DETERMINE THE NECESSITY FOR PRE-DILATION? NO DILATION. WAS RESISTANCE ENCOUNTERED WHEN ADVANCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152445 ↗
• MalfunctionMay 6, 2026Break; Fracture

  THE STENT TIP IS BROKEN INSIDE THE PATIENT'S BODY AND CANNOT BE RELEASED NORMALLY. AFTER RETRACTION, A BALLOON IS USED FOR DILATION. 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? STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? COLONOSCOPY. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? METII-35-480. 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. INTESTINE. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? STENT WAS REMOVED IMMEDIATELY. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE? YES. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? YES. WAS ANY PART OF THE STENT OBSERVED IN CONTACT WITH THE PATIENT¿S ANATOMY AT THE TIME OF FAILURE? YES. WAS THE YELLOW MARKER KEPT IN VIEW DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25098861 ↗
• MalfunctionApr 23, 2026Physical Resistance/Sticking

  WHEN STENT WAS FULLY DEPLOYED , A SMALL PART OF FLANGE WAS STILL STUCK IN THE DELIVERY SYSTEM AND DID NOT DEPLOY PROPERLY EVEN AFTER THE DEPLOYMENT TRIGGER BUTTON ON THE DELIVERY SYSTEM WAS FULLY PULLED TILL THE STENT DEPLOYMENT INDICATOR CAME TO THE END OF THE DELIVERY HANDLE, THE STENT CAME OUT WITH THE DELIVERY SYSTEM. PHYSICIAN USED ANOTHER EVOLUTION STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965998 ↗
• MalfunctionApr 23, 2026Physical Resistance/Sticking

  LAST WEEK THE TEAM USED AN UNCOVERED STENT. THE STENT WAS DEPLOYED (NOT FULLY) BUT WASN'T IN THE CORRECT POSITION SO NEEDED TO BE ALTERED, HOWEVER WHEN THE TEAM ATTEMPTED TO RE-SHEATH IT, IT UNFORTUNATELY WOULD NOT RETRACT FULLY. THE STENT HAD NOT BEEN DEPLOYED BEYOND THE POINT OF NO RETURN AT ANY STAGE. AS THE STENT COULD NOT BE FULLY RE SHEATHED, IT HAD TO BE COMPLETELY REMOVED, AND A DIFFERENT STENT WAS USED INSTEAD. I¿VE ATTACHED A PHOTO SHOWING THE END OF THE STENT FOR REFERENCE. WHAT WAS THE TARGET LOCATION? RIGHT HEPATIC DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? ACROBAT WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? NO WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? WIRE PASSED WITHOUT DIFFICULTY IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY) NO; STANDARD ANATOMY WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? PERIHILAR 2CM WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO WAS AN ASSESSMENT CARRIED OUT TO DETERMINE THE NECESSITY OF PRE-DILATION? ALMOST NEVER PREDILATE WAS THE SAFETY WIRE REMOVED? IF YES, AT WHAT POIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965765 ↗
• MalfunctionApr 14, 2026Activation Failure; Physical Resistance/Sticking

  ECHEC DE POSE TO BE CONFIRMED. CUSTOMER DID NOT ANSWER THE EMAILS FROM SSC AND SBU.BUT THEY TOLD THE SBU THAT THIS DEVICE WAS USED IN DECEMBER 202526-MAR-26: PROBLEM FOR THE STAFF WHO WERE UNABLE TO REMOVE THE PIN (GOUPILLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875043 ↗

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