Evolution G51182Recalls & reported problems
Cook Ireland Ltd · EVOLUTION ESOPHAGEAL, STENT SYSTEM - FULLY COVERED · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002511825), received between May 16, 2017 and May 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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
Device problems
- Activation, Positioning or Separation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
ADDITIONAL INFORMATION RECEIVED ON THE 18-APR-2017 THAT THE STENT WAS NOT FULLY RETRACTED ON REMOVAL FROM THE PATIENT. THIS INITIAL MDR IS BEING SUBMITTED BASED ON THE MALFUNCTION PRECEDENCE OF 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM'. AS REPORTED TO CUSTOMER RELATIONS: "THE PHYSICIAN DEPLOYED BUT WOULD NOT RELEASE FROM DEPLOYMENT DEVICE. REMOVED THE DEVICE FROM THE PATIENT AND USED A BOSTON SCIENTIFIC STENT TO COMPLETE THE PROCEDURE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6568452 ↗
Other PROSTHESIS, ESOPHAGEAL devices
- WallFlex™ Esophageal M00516730Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall29 reports
- WallFlex™ Esophageal M00516740Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death22 reports
- WallFlex™ Esophageal M00516750Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death19 reports
- WallFlex™ Esophageal M00516700Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall18 reports
- WallFlex™ Esophageal M00516910Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall15 reports
- WallFlex™ Esophageal M00516930Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall14 reports
- WallFlex™ Esophageal M00516710Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall13 reports
- WallFlex™ Esophageal M00516940Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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