URO-GUIDE 5496024Recalls & reported problems
Gyrus ACMI, LLC · 6.0FR (2.0mm) X 24 cm URO-GUIDE URETERAL STENT · Class 2 · Implant
- 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 00821925004122), received between Oct 10, 2024 and Oct 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
MalfunctionOct 10, 2024Migration; Migration
IT WAS REPORTED THAT THE URETERAL STENT IMPLANTED AND REMAINED IN PATIENT OVER TIME CAUSED ¿SLIPPAGE¿ AND PATIENT DISCOMFORT. THERE WAS NO MEDICAL INTERVENTION OR ADDITIONAL PROCEDURE REQUIRED DUE TO STENT MIGRATION. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, OR THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT. THE ISSUE WAS FOUND DURING A STENT PLACEMENT PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20423168 ↗
Other Stent, Ureteral devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.