UroStream G59156Recalls & reported problems
Cook Incorporated · UroStream Hydrophilic Wire Guide · Class 2
- 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 00827002591561), received between Apr 6, 2026 and Apr 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Peeled/Delaminated
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE COATING OF 'UROSTREAM HYDROPHILIC WIRE GUIDE' CAME OFF. THE WIRE GUIDE WAS NOT USED THROUGH A NEEDLE. UNSPECIFIED STENTS WERE USED WITH THE WIRE GUIDE. RESISTANCE WAS OBSERVED WHEN THE USER TRIED TO RELEASE THE STENT. THE COATING CAME OFF AND THE METAL WAS EXPOSED DURING REMOVAL OF GUIDEWIRE AFTER PLACEMENT OF THE STENTS. THE PROCEDURE WAS COMPLETED BY STARTING WITH A NEW WIRE AND REMOVING AND REPLACING ALL STENTS. PER THE REPORTER, SOME OF THE COATING WAS "STUCK" IN THE STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792761 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.