PTFE Coated Urological Guidewire M0066201050Recalls & reported problems
Lake Region Medical Limited · 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 08714729012634), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture1
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.
MalfunctionMar 18, 2021Fracture; Fracture
PER SALESFORCE COMPLAINT ID (B)(4), IT WAS REPORTED THAT: PHYSICIAN WAS HAVING DIFFICULTY PASSING STENT OVER WIRE. WITHDREW BOTH STENT AND WIRE, NOTED STENT BUNCHED UP ON WIRE, CUT STENT OFF. WIRE APPEARED ELONGATED. - DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) - WHAT TROUBLESHOOTING STEPS TOOK PLACE? REPLACED WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11514788 ↗
Other Stylet For Catheter, Gastro-Urology devices
- NiCore Nitinol Guidewire 150NSS35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY229 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page