STATLOCK VPPDFPRecalls & reported problems
Bard Access Systems, Inc. · StatlockTM Stabilization devices (PICC Plus, Crescent Foam Pad, Fixed Post Retainer) · 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 00801741083389), received between Feb 20, 2018 and May 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Difficult to Remove1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT STAT LOCK FOR PICC LINE OPENED AND CLEAR CLIP PORTION WAS NOT ATTACHED TO THE ADHESIVE BACKING. UNABLE TO USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371373 ↗MalfunctionApr 23, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVED A STATLOCK FROM PATIENT PRIOR TO DRESSING CHANGE PROCEDURE, HAD A VERY DIFFICULT TIME REMOVING IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9990450 ↗MalfunctionFeb 20, 2018Loss of or Failure to Bond
IT WAS REPORTED THAT THE ADHESIVE ON THE STATLOCK WAS NOT HOLDING. IT WAS STATED THE ADHESIVE DID NOT LAST A FULL DAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7283641 ↗
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.