Grip-Lok 3400LFCRecalls & reported problems
Tidi Products, LLC · Large Foley Catheter Securement Device, For 2 & 3 way Foley Catheters sized 8-30 Fr · 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 00618125134779), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
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.
MalfunctionJun 7, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE CUSTOMER: "I'M 71 YEARS OLD, AND I CLEAN AND DRY MY LEG CORRECTLY, SO IT'S NICE AND DRY. I HAVE NO HAIR ON THAT PART OF MY BODY BECAUSE, LUCKY FOR ME, I'M NOT A HAIRY PERSON. JUST TO CLARIFY IT FOR YOU, THE GRIP-LOK REMAINS ON MY LEG BEAUTIFULLY, BUT THE WHITE LAYER ON TOP THAT SECURES THE CATHETER TUBE COMES OFF WITHIN A FEW DAYS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491256 ↗
Other Holder, Ureteral Catheter devices
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- 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
- Catheter Stabilization Device VFDSSPC. R. Bard, Inc. · HOLDER, URETERAL CATHETER3 reports
- Medline SAFESECUREMedline Industries, Inc. · HOLDER, URETERAL CATHETER3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.