Grip-Lok 3400LFC-10PKRecalls & reported problems
Tidi Products, LLC · Grip-Lok Foley Securement Device White Loop/Hook/Foam/Bandage/Liner Sterile Large 10 per Package · Class 1
All models of Grip-Lok (11)
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 00618125134786), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
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.
MalfunctionDec 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
AMAZON REVIEW: I USED THE 1ST OF THESE YESTERDAY; IT DIDN'T EVEN LAST 12 HOURS BEFORE IT TOTALLY CAME OFF. I EVEN USED A BARRIER CREAM THAT IS SUPPOSED TO HELP IT STICK BETTER. TODAY I DECIDED I'D LET IT SET LONGER BEFORE I HOOKED MY CATHETER TUBES IN IT. WITHIN AN HOUR, IT WAS ALREADY COMING LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020174 ↗
Other Holder, Ureteral Catheter devices
- Catheter Stabilization Device FOL0102C. R. Bard, Inc. · HOLDER, URETERAL CATHETER375 reports
- Catheter Stabilization Device FOL0101C. R. Bard, Inc. · HOLDER, URETERAL CATHETER240 reports
- Catheter Stabilization Device FOL0100C. R. Bard, Inc. · HOLDER, URETERAL CATHETER147 reports
- Catheter Stabilization Device FOL0105C. R. Bard, Inc. · HOLDER, URETERAL CATHETER24 reports
- Medline SNAPSECURE3WMedline Industries, Inc. · HOLDER, URETERAL CATHETER22 reports
- Medline SNAPSECUREMedline Industries, Inc. · HOLDER, URETERAL CATHETER7 reports
- Medline SAFESECUREMedline Industries, Inc. · HOLDER, URETERAL CATHETER3 reports
- Catheter Stabilization Device VFDSSPC. R. Bard, Inc. · HOLDER, URETERAL CATHETER3 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.
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