UroStream G59153Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002591530), received between Jan 11, 2024 and Dec 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Peeled/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 23850119 ↗
• MalfunctionJun 30, 2025Inadequate Lubrication; Inadequate Lubrication

  IT WAS REPORTED PRIOR TO A RETROGRADE INTRARENAL SURGERY (RIRS), A UROSTREAM HYDROPHILIC WIRE GUIDE FELT SLUGGISH AND GOT STUCK DURING INSERTION INTO THE SCOPE. PRIOR TO INSERTION, THE WIRE GUIDE WAS HYDRATED AND KEPT WET WHEN NOT IN USE. REPORTEDLY, THE WIRE FELT "TORN UP, SPIKY". THE PHYSICIAN REPORTED IT MIGHT BE DUE TO THE SCOPE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358042 ↗
• MalfunctionApr 22, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE UROSTREAM HYDROPHILIC WIRE GUIDE¿S COATING "REMOVED" DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE ISSUE WAS FOUND WHEN THE WIRE GUIDE WAS PLACED INTO THE INSTRUMENT. THERE WAS NO RESISTANCE DURING PLACEMENT OR WITHDRAWAL OF THE WIRE GUIDE, WHICH WAS ACTIVATED WITH WATER, BUT WAS NOT REACTIVATED BEFORE EACH RE-USE. NO OTHER DEVICES WERE USED WITH THE DEVICE. THE WIRE GUIDE WAS USED ONCE DURING THE PROCEDURE AND TWO WIRE GUIDES EXPERIENCED THE SAME ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881069 ↗
• MalfunctionOct 7, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE UROSTREAM HYDROPHILIC WIRE GUIDE PEELED DURING A STENT REMOVAL PROCEDURE FROM THE KIDNEY, URETER AND BLADDER OF A MALE PATIENT OF UNKNOWN AGE. THE PATIENT HAD CALCIFIED STENT PIECES AND A CALCULUS IN THE URETER. TO MINIMIZE DILATION OF THE URETER AND FACILITATE SAFER NAVIGATION OF THE RIGID URETERORENOSCOPE, TWO WIRE GUIDES, THE BI WIRE AND UROSTREAM, WERE USED SIMULTANEOUSLY. AS THE DOCTOR REACHED THE STENT FRAGMENTS AND THE STONE, THE UROSTREAM GUIDE WAS REMOVED TO MAKE ROOM FOR INSERTION OF A BASKET. HOWEVER, DUE TO LIMITED SPACE IN THE URETERAL LUMEN, THE GUIDEWIRE LIKELY HIT THE TIP OF THE RIGID SCOPE DURING ITS REMOVAL, CAUSING THE GUIDEWIRE JACKET TO PEEL. ONCE IT WAS CONFIRMED THAT NO REMNANTS OF THE GUIDEWIRE JACKET WERE LEFT INSIDE URETER, THE DOCTOR PROCEEDED WITH THE PROCEDURE, SUCCESSFULLY REMOVING THE STENT FRAGMENTS USING A NITINOL BASKET. AS REPORTED, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385967 ↗
• MalfunctionJan 11, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A URETEROSCOPY (URS) AND LASER LITHOTRIPSY, THE UROSTREAM HYDROPHILIC WIRE GUIDE SHREDDED. SALINE WAS PASSED THROUGH THE WIRE HOUSING TO ACTIVATE THE COATING. THE COATING OF THE DEVICE WAS REACTIVATED BEFORE USING THE WIRE GUIDE FOR A SECOND PASS. DURING THE SECOND PASS OF THE WIRE GUIDE, PIECES OF WIRE GUIDE JACKET WERE COMING OFF. THE PHYSICIAN EXPRESSED THAT THE WIRE WAS BEGINNING TO FEEL TACKY. AN NCIRCLE STONE EXTRACTOR WAS USED TO REMOVE THE SEPARATED PIECES OF THE DEVICE FROM THE PATIENT, DURING THE SAME PROCEDURE. A MOTION WIRE GUIDE WAS THEN USED TO COMPLETE THE PROCEDURE AS NORMAL. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499581 ↗