SOLO PLUS Stiff Hybrid Guidewires HW35SAJRecalls & reported problems
Heraeus Medical Components LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816840020463), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN CUSTOMER STARTED USING GUIDEWIRE, THE TIP BROKE OFF IMMEDIATELY. ALL ITEMS FROM THE SAME LOT WERE COLLECTED, AND THE CUSTOMER REQUESTED THAT ALL BE INVESTIGATED. A TOTAL OF 4 BOTTLES WERE IN STORAGE, BUT 3 OF THE 4 ARE UNOPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925904 ↗
Other Stylet For Catheter, Gastro-Urology devices
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- Sensor M0066703050Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY41 reports
- Bard® Hydro-Glide™ Guidewire 145FS35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY31 reports
- NiCore Nitinol Guidewire 150NFS35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY30 reports
- Amplatz Super Stiff M0066401090Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY21 reports
- Amplatz Super Stiff M0066401080Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY18 reports
- Sensor M0066703120Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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