UroStream G59151Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002591516), received between Sep 8, 2023 and Aug 4, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134515 ↗
• MalfunctionSep 19, 2024Peeled/Delaminated; Peeled/Delaminated

  AS INITIALLY REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), IF THE UROSTREAM HYDROPHILIC WIRE GUIDE HAS TO BE RETRACTED THROUGH THE NEEDLE, THE WIRE OFTEN SHEARS. IN THIS CASE THE WIRE DID NOT SHEAR OR SEPARATE, "BUT YOU COULD SEE AND FEEL THE AREA WHERE IT STARTED TO". ANOTHER WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. THE COATING OF THE WIRE GUIDE WAS ACTIVATED WITH STERILE WATER THRU A SYRINGE AND IN A BASIN OF WATER. THE DEVICE WAS RETURNED 28AUG2024. INSPECTION OF THE DEVICE FOUND THERE WAS AN 8MM AREA WHERE THE COATING IS PARTIALLY PEELED FROM THE INNER CORE, APPROXIMATELY 7CM FROM THE FLEXIBLE TIP. NO PIECE OF THE WIRE CAME OFF OR WAS LEFT INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260255 ↗
• MalfunctionMar 27, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), THE COATING OF A UROSTREAM HYDROPHILIC WIRE GUIDE WAS ACTIVATED WITH STERILE WATER USING A SYRINGE. THE WIRE GUIDE WAS PLACED THROUGH A COOK MEDICAL 18 GAGE CHIBA BIOPSY NEEDLE. THERE WAS NO RESISTANCE NOTED DURING WIRE GUIDE INSERTION. WHEN REMOVING THE WIRE GUIDE FROM THE NEEDLE, THE COATING OF THE WIRE GUIDE SEPARATED. THE SEPARATED COATING WAS REMOVED FROM THE PATIENT USING A "GRASPER," AND A NEW WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987990 ↗
• MalfunctionFeb 23, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

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

  MAUDE report 18771206 ↗
• MalfunctionDec 19, 2023Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358029 ↗
• InjurySep 8, 2023Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713307 ↗