STATLOCK NN0201Recalls & reported problems
Bard Access Systems, Inc. · SL PICC II BD/TYCO · Class 1
- 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 00801741082870), received between Feb 3, 2025 and Jun 23, 2026 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
- Misconnection1
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.
MalfunctionJun 23, 2026Misconnection
IT WAS REPORTED THAT UNCLAMPED PICC LINE FROM ROLL TO ACCESS 4-WAY CONNECTOR. IT WAS AT THIS TIME THAT WRITER FELT 28G LINE COMPLETELY DISCONNECT FROM PINK HUB WHICH ATTACHES TO STATLOCK. LINE WAS COMPLETELY COMPROMISED SO CLINICIAN WAS IMMEDIATELY CALLED TO ATTEMPT NEW ACCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600757 ↗MalfunctionFeb 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED, WHILE DOING THE PICC DRESSING CHANGE ON PATIENT, THE BLUE PART THAT HOLDS THE PICC IN PLACE DETACHED FROM THE ADHESIVE PART THAT STICKS ON THE PATIENT. THIS CAUSED THE PICC TO MOVE 1CM. THE PICC LINE WAS IN PLACE FOR CHEMOTHERAPY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21297083 ↗
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.