STATLOCK IV0520Recalls & reported problems
Bard Access Systems, Inc. · StatLock™ Stabilization Device(IV Ultra) · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000270), received between Apr 27, 2017 and Aug 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Misconnection” (2 reports).
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
- Misconnection2
- Sticking2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Skin Tears1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136786 ↗MalfunctionJul 10, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781953 ↗MalfunctionFeb 12, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED, " IT IS DIFFICULT REMOVING THE STATLOCK FROM THE PATIENT. PATIENT HAD A SMALL SKIN TEAR. THEY ARE USING ALCOHOL WIPE TO GET THE ADHESIVE OFF AND IT IS NOT COMING OFF. STAT LOCK IV IV0520." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Skin Tears
MAUDE report 18686311 ↗MalfunctionApr 27, 2017Sticking
IT WAS REPORTED BY THE FACILITY THAT THE IV STATLOCK IS EXCESSIVELY "STICKY" WHEN USED WITH POWERGLIDE PRO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6527122 ↗MalfunctionApr 27, 2017Sticking
IT WAS REPORTED BY THE FACILITY THAT THE IV STATLOCK IS EXCESSIVELY "STICKY" WHEN USED WITH POWERGLIDE PRO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6527118 ↗
Other DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices
- STATLOCK PIC0220Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT47 reports
- STATLOCK VPPCSPBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK CV0220CEBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK PIC0222Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT18 reports
- Catheter Stabilization Device NG0120C. R. Bard, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT1 death13 reports
- STATLOCK VUPD1214Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT13 reports
- BD PhaSeal™ Optima Infusion Clamp M25-O 515085Becton Dickinson Pen Limited · DEVICE, INTRAVASCULAR CATHETER SECUREMENT12 reports
- Grip-Lok 3601CVCTidi Products, LLC · Device, Intravascular Catheter Securement12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.