UroWire® Guidewire with SL-6® Hydrophilic Coating B8634Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915113858), received between Sep 26, 2016 and Jul 9, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 9, 2019Material Separation; Material Separation

  PROCEDURE PERFORMED: UNKNOWN. SUSPECTED FAULTY PRODUCT WHEN OPENED OUT OF STERILE PACK BEFORE USE. NO FURTHER INFORMATION IS KNOWN AND WAS NOT PASSED ON MY MEDICAL STAFF TO CLINICAL PROCUREMENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM ACCOUNT MANAGER ON WEDNESDAY 19JUN2019: THE GUIDE WIRE HAD BEEN REVERSED LOADED ( INCORRECTLY BY MANUFACTURE), THE HYDROPHILIC COATING OF WIRE SHREDDED INSIDE KIDNEY AND HAD TO BE CAREFULLY REMOVED BEFORE SURGERY COULD RECOMMENCE. PATIENT STATUS: NON. TYPE OF INTERVENTION: THE HYDROPHILIC COATING OF WIRE SHREDDED INSIDE KIDNEY AND HAD TO BE CAREFULLY REMOVED BEFORE SURGERY COULD RECOMMENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773599 ↗
• MalfunctionDec 21, 2016Detachment Of Device Component; Detachment Of Device Component

  CYSTOSCOPY, URETEROSCOPY - "DURING CYSTOSCOPY THE BLUE SHEATH SEPARATED AND SPLINTERED FROM THE GUIDEWIRE, DR WAS UNABLE TO USE ITEM FURTHER." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6197130 ↗
• MalfunctionDec 8, 2016Detachment Of Device Component; Detachment Of Device Component

  CYSTOSCOPY, URETEROSCOPY, DYELOGRAM - "BLUE COATING SEPARATED FROM WIRE WHEN SURGEON TRIED TO REMOVE THE WIRE VIA THE SCOPE. WIRE GOT STUCK AND HAD TO BE REMOVED WITH FORCE." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6155420 ↗
• MalfunctionNov 8, 2016Break; Break

  "WIRE STRIPPED WHILE THREADING THROUGH SCOPE." ADDITIONAL INFORMATION RECEIVED BY EMAIL ON OCTOBER 12, 2016. THE PART THAT STRIPPED WAS THE END OF THE WIRE THAT ENTERED THE SCOPE FIRST. THE WIRE GOT STUCK AND ONCE REMOVED THE SURGEON INDICATED THAT THE WIRE HAD STRIPPED. THIS WAS DURING THE START OF THE PROCEDURE WHERE THE SURGEON FEED THE WIRE THROUGH THE SCOPE INTO THE URETER. NO PART OF THE ITEM WAS LEFT INSIDE THE PATIENT. NO SHARP INSTRUMENTS WERE USED. WE OPENED ANOTHER WIRE FOR THE SURGEON TO USE. PATIENT STATUS: "PATIENT IS FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6088140 ↗
• MalfunctionSep 26, 2016Detachment Of Device Component; Detachment Of Device Component

  LASER LEFT KIDNEY STONE. "PLASTIC COVERING CAME OFF DURING OPERATION". ADDITIONAL INFORMATION RECEIVED ON 26TH AUGUST 2016. NO, THE WIRE DID NOT COME IN CONTACT WITH A SHARP OBJECT, IT WAS JUST PASSED THROUGH THE URETEROSCOPE. NO PICTURE AVAILABLE. SMALL PLASTIC FRAGMENT WAS REMOVED FROM PATIENT AND INSERTED IN PACKAGING WITH GUIDE WIRE AND GIVEN BACK TO OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5978871 ↗