Sensor M0066703100Recalls & reported problems
Boston Scientific Corporation · Nitinol Wire with Hydrophilic Tip · Class 1
- 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 08714729752868), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material1
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.
MalfunctionNov 26, 2024Unraveled Material; Unraveled Material
IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY WITH URETEROSCOPY PROCEDURE, THE SENSOR WIRE WAS GOING TO BE USED. UPON UNPACKING, IT WAS NOTICED THAT THE BACK END OF THE GUIDEWIRE WAS FRAYED OUT OF THE HOUSING, AND IT WAS REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSOR WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788466 ↗
Other STYLET FOR CATHETER, GASTRO-UROLOGY devices
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- Sensor M0066703080Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY118 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.