SLP001Recalls & reported problems
Bard Access Systems, Inc. · StatLock Pro, single · 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 00801741182822), received between Sep 8, 2025 and Sep 8, 2025 — classified as 2 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
- Product Quality Problem1
Patient problems
- Insufficient Information2
- 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.
MalfunctionSep 8, 2025Misconnection; Misconnection
IT WAS REPORTED THAT STATLOCK-PRO HAS BROKEN. IT HAS CRACKED ON ONE WING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22995134 ↗MalfunctionSep 8, 2025Misconnection; Product Quality Problem; Misconnection; Product Quality Problem
ADDITIONAL INFORMATION RECEIVED ON 9/2/2025: CUSTOMER REPORTS THE WING IS CRACKING WHEN APPLYING THE STATLOCK. THERE HAVE NOT BEEN ANY DISLODGED CATHETERS AND NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22995130 ↗
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.