SOLO FLEX Hybrid Guidewires HW35FARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816840020357), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Accessory Incompatible” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS UNDERGOING URETEROSCOPY, A GUIDE WIRE WAS USED TO ESTABLISH A WORKING CHANNEL. DURING THE OPERATION, THE GUIDE WIRE WAS PULLED OUT AND PLACED IN THE BASIN ON THE OPERATING TABLE. WHEN THE OPERATION WAS ALMOST OVER, THE GUIDE WIRE WAS ACTIVATED AND USED TO PLACE A URETERAL STENT. IT WAS FOUND THAT THE STENT COULD NOT BE PUSHED IN, AND THE SHEATH OF THE GUIDE WIRE FELL OFF. A NEW GUIDE WIRE WAS REPLACED, AND THE STENT WAS SUCCESSFULLY PLACED. PATIENT HAS BEEN EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 04MAR2025, STATED THAT THE PATIENT WAS NOT HARMED BY THE DEVICE. THE URETERAL SHEATH HAS NOT FALLEN OFF.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21547561 ↗