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Catheter Stabilization Device VFDSSPRecalls & reported problems

C. R. Bard, Inc. · StatLock Foley Stabilization Devices, Catheter Stabilization Devices, Large Swivel Clamp on pediatric pad, includes: skin prep pad · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741076053), received between Sep 20, 2022 and Apr 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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

  • Difficult to Open or Close1
  • Disconnection1
  • Fitting Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 27, 2023Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT THE FOLEY STAT LOCKS OF VFDSSP OF LOT# JUGUH683 AND ANOTHER STATLOCK FOL0102 OF LOT#: JUGT2307 WILL NOT REMAIN CLOSED NO MATTER THE PRESSURE APPLIED, AND USER HAD TO USE ZIP TIES TO SECURE THE LOCKS IN PLACE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16824805 ↗
  • MalfunctionSep 20, 2022Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE FOLEY STATLOCK DEVICE SECURING 14FR FOLEY CATHETERS. STATED THAT THEY USED FOLEY STATLOCK PEDIATRIC FOR SIL CATH (VFDSSP) AND FOLEY STATLOCK ADLT FOR SIL CATH (FOL0100). STATED THAT THEY WERE HAVING ISSUES WHEN USING WITH THE 14FR CATHETER, IT WOULD CLOSE, BUT IT DID NOT LATCH PROPERLY AND COULD POP OPEN (PCN# VFDSSP) AND (PCN# FOL0100), AND ALSO STATED THAT THE ONE CATHETER UNABLE TO FIT AT ALL (PCN# VFDSSP) AND ( PCN# FOL0100).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15455207 ↗
  • MalfunctionSep 20, 2022Disconnection; Disconnection

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE FOLEY STATLOCK DEVICE SECURING 14FR FOLEY CATHETERS. STATED THAT THEY USED FOLEY STATLOCK PEDIATRIC FOR SIL CATH (VFDSSP) AND FOLEY STATLOCK ADLT FOR SIL CATH (FOL0100). STATED THAT THEY WERE HAVING ISSUES WHEN USING WITH THE 14FR CATHETER, IT WOULD CLOSE, BUT IT DID NOT LATCH PROPERLY AND COULD POP OPEN AND ALSO STATED THAT THE ONE CATHETER UNABLE TO FIT AT ALL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15454977 ↗

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.