SOLO FLEX Hybrid Guidewires HW35FSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816840020333), received between Oct 24, 2017 and Sep 9, 2024 — classified as 2 injuries, 2 malfunctions.

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

• InjurySep 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT GUIDEWIRE PIECE WAS FOUND IN THE PATIENT AFTER A CASE PERFORMED BY SURGEON. THE GUIDEWIRE PIECE BROKE OFF DURING SURGERY AND WAS FOUND USING X-RAY AND REMOVED FROM THE PATIENT. PATIENT HAD TO HAVE SECOND SURGERY DUE TO GUIDEWIRE PIECE BEING STUCK IN THEIR URINARY TRACT. THERE WAS PAIN AND DISCOMFORT. PER CLINICAL FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 16-OCT-2024, THE 61-YEAR-OLD MALE HAD A KIDNEY STONE AND REQUIRED SURGERY ON (B)(6) 2024. PRIOR TO USE, THERE WERE NO ISSUES NOTED WITH THE DEVICE. THE PATIENT LATER CAME IN FOR AN INFECTION, AND THE BROKEN PIECE OF GUIDEWIRE WAS IDENTIFIED BY X-RAY. ON (B)(6) 2024, THE PATIENT HAD SURGERY TO REMOVE THE GUIDEWIRE FRAGMENT. THE DIRECTOR OF NURSING CONFIRMED THE PIECE LOOKED TO BE THE END OF THE SOLO PLUS GUIDEWIRE. THERE WAS NO ADDITIONAL PATIENT IMPACT FOLLOWING THE SECOND SURGERY.

  Patient problems: Discomfort; Foreign Body In Patient; Pain; Unspecified Infection

  MAUDE report 20169010 ↗
• InjuryJun 1, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A CYSTOSCOPY, URETEROSCOPY, AND LASER LITHOTRIPSY DIRECTLY WITH STONE EXTRACTION, PART OF THE HYDROPHILIC GUIDEWIRE WAS RETAINED IN THE LEFT URETER OF THE PATIENT. ATTEMPTS TO REMOVE THE PART OF THE GUIDEWIRE WERE UNSUCCESSFUL. THE SURGERY WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO ICU AND LATER DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7560860 ↗
• MalfunctionOct 24, 2017Peeled/Delaminated

  IT WAS REPORTED THAT THERE WAS FLAKING FROM THE GUIDEWIRE DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6974219 ↗
• MalfunctionOct 24, 2017Flaked

  IT WAS REPORTED THAT THERE WAS FLAKING FROM THE GUIDEWIRE DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973889 ↗