Grip-Lok 3300MWARecalls & reported problems
Tidi Products, LLC · Medium Universal Securement with Wide Silicone Adhesive Area · Class 1
All models of Grip-Lok (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00618125134748), received between Mar 10, 2023 and Feb 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED BY A DISTRIBUTOR THAT THAT END USER IS FINDING PRODUCT DOES NOT STAY ADHERED TO PATIENTS SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18647503 ↗MalfunctionMar 10, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED BY VYGON, TIDI'S MEDICAL DEVICE DISTRIBUTOR IN ITALY: ¿THE DEVICE PRESENTED CRITICALITIES IN ITS AFFIXING AND REMOVAL: IN THE LATTER MANEUVER, IN FACT, THE FIXATION WAS SO ADHERENT AS TO RISK COMPROMISING THE INTEGRITY OF THE SKIN AND ACCIDENTALLY PULLING OUT THE CATHETER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526631 ↗
Other Device, Intravascular Catheter Securement devices
- STATLOCK PIC0220Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT47 reports
- STATLOCK CV0220CEBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK VPPCSPBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK PIC0222Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT18 reports
- STATLOCK VUPD1214Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT13 reports
- Catheter Stabilization Device NG0120C. R. Bard, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT1 death13 reports
- Grip-Lok 3601CVCTidi Products, LLC · Device, Intravascular Catheter Securement12 reports
- BD PhaSeal™ Optima Infusion Clamp M25-O 515085Becton Dickinson Pen Limited · DEVICE, INTRAVASCULAR CATHETER SECUREMENT12 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.
How reports and recalls are matched · Editorial policy · Report an error on this page