ZIPwire™ M0066802210Recalls & reported problems
Lake Region Medical · Urological guidewire · 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 00816349011818), received between Nov 28, 2023 and Nov 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
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 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT DESCRIPTION: AS REPORTED, THE GUIDEWIRE FAILED AND WAS STRIPPED DURING THE PROCEDURE. NO HARM TO THE PATIENT AND EVERYTHING WAS RETRIEVED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18222223 ↗
Other Stylet, Ureteral devices
- ZIPwire™ M0066802220Lake Region Medical · Stylet, Ureteral46 reports
- ZIPwire™ M006630222B0Lake Region Medical · Stylet, Ureteral21 reports
- OLYMPUS GWH3505RGyrus ACMI, LLC · STYLET, URETERAL16 reports
- ZIPwire™ M006630205B0Lake Region Medical · Stylet, Ureteral10 reports
- ZIPwire™ M0066802050Lake Region Medical · Stylet, Ureteral9 reports
- ZIPwire™ M0066802080Lake Region Medical · Stylet, Ureteral9 reports
- ZIPwire™ M006630209B0Lake Region Medical · Stylet, Ureteral5 reports
- OLYMPUS GWH3505RAGyrus ACMI, LLC · STYLET, URETERAL5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.