SOLO PLUS Stiff Hybrid Guidewires HW35SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816840020296), received between May 10, 2018 and Mar 24, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Flaked” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Material Fragmentation

  IT WAS REPORTED THAT THE FLOPPY TIP OF THE GUIDEWIRE DETACHED DURING THE CASE. THE PHYSICIAN SPENT 1.5 HOURS RETRIEVING THE FLOPPY TIP OF THE GUIDEWIRE IN THE PATIENT. THE PHYSICIAN NOTICED AFTER THE CASE PART OF THE GUIDEWIRE WAS MISSING AND WAS ABLE TO REMOVE ALL PIECES. PATIENT WAS UNDER ANESTHESIA 1.5 LONGER THAN EXPECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24683061 ↗
• InjuryJul 16, 2025Flaked; Material Split, Cut or Torn; Flaked; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. THE HYBRID GUIDEWIRE (B)(6) WAS USED FOR THE FIRST TIME. IT WAS SMOOTH AND NORMAL WHEN IT WAS INSERTED. AFTER A PERIOD OF TIME, THE STENT WAS PLACED OVER THE GUIDEWIRE. IT WAS FOUND THAT THE GREEN COATING AT THE END OF THE GUIDEWIRE FELL OFF AND WAS WRAPPED WITH THE STENT, ALMOST FALLING ON THE PATIENT. THE DOCTORS INTRAOPERATIVELY COMMUNICATED IN BETWEEN AND TRIED EVERY MEANS TO REMOVE THE COATING, WHICH HAD SOME IMPACT ON THE CLINICAL OPERATION AND PROLONGED THE OPERATION TIME. AT THE SAME TIME, THE DOCTOR HAD GREAT DOUBTS ABOUT THE QUALITY OF THE PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22522109 ↗
• InjuryOct 23, 2019Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE WIRE AND STENT (B)(4) COILED IN THE RENAL PELVIS. A LEFT URETERAL STENT WAS ATTEMPTED. UNDER FLUOROSCOPY AS THE WIRE WAS BEING REMOVED THE STENT APPEARED TO BE BENDING AND PLEATING OVER THE WIRE. AT THIS TIME THE STENT BUT WAS NOT DISENGAGED FROM THE WIRE. SEVERAL ATTEMPTS WERE MADE TO PULL THE WIRE OUT OF THE STENT, AND IT WOULD NOT DISENGAGE. ULTIMATELY THE WIRE AND STENT WERE REMOVED THROUGH THE PENIS. THE WIRE APPEARED TO HAVE BEEN EMBEDDED AND ENGAGED HALFWAY THROUGH THE STENT., THE STENT WAS THEN CUT. ANOTHER ATTEMPT WAS MADE TO THREAD A WIRE THROUGH THIS STENT USING A HYDROPHILIC WIRE BUT UNFORTUNATELY THE TIP OF THE REMAINING STENT WAS IN THE BLADDER AND HAD ALREADY DISENGAGED THE URETERAL ORIFICE. THE CYSTOSCOPE WAS THEN REPLACED AND IT WAS NOTED THE PROCESS OF REMOVING THE STENT HAD CAUSED CONSIDERABLE SWELLING AND EDEMA AROUND THE LEFT URETERAL ORIFICE WHICH WAS ALSO BLEEDING. THE PATIENT WAS ADMITTED TO OBSERVATION AND HAD AT PLACEMENT OF A PERCUTANEOUS NEPHROSTOMY TUBE.

  Patient problems: Blood Loss; Edema; Swelling

  MAUDE report 9227263 ↗
• MalfunctionMay 10, 2018Flaked; Flaked

  IT WAS REPORTED THAT "THE THE SURFACE OF THE GUIDEWIRE WAS FLAKE WHILE MANIPULATING THE DEVICE, AND A FLAKED PIECE WAS REMAINING IN THE PATIENT. A LAPAROTOMY WAS PERFORMED TO REMOVE THE REMAINING."

  Patient problems: Foreign Body In Patient

  MAUDE report 7503889 ↗