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Catheter Stabilization Device VFDSPRecalls & reported problems

C. R. Bard, Inc. · StatLock Foley Stabilization Devices, Catheter Stabilization Devices, Swivel Clamp on pediatric pad, includes: skin prep pad · 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 00801741076039), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Fitting Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 6, 2019Fitting Problem; Fitting Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE USER WAS DISSATISFIED WITH THE OVERALL PERFORMANCE OF THE PRODUCT. THE RESPONDENT SAID THE STATLOCK WAS AN UNSTABLE SITUATION TO A SHORT PERIOD OF TIME.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9430507 ↗

Other HOLDER, URETERAL CATHETER devices

All HOLDER, URETERAL CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.