StatLock 0684000472Recalls & reported problems
Bard Access Systems, Inc. · StatLock Stabilization Devices for MAQUET Intra-Aortic Balloon (IAB) Catheter · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741081248), received between Oct 18, 2024 and May 18, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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
- Contamination /Decontamination Problem3
- Tear, Rip or Hole in Device Packaging2
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT MULTIPLE POUCHES HAD PRINTING DEFECTS THAT IMPACTED LEGIBILITY. IT WAS REPORTED THAT THIS OCCURRED WITH 7 DEVICES. THIS REPORT COVERS ALL 7 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25208031 ↗MalfunctionMar 4, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOREIGN MATTER FOUND IN PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513372 ↗MalfunctionMar 4, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOREIGN MATTER FOUND IN PACKAGING. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507969 ↗MalfunctionJan 22, 2026Contamination /Decontamination Problem
IT WAS REPORTED DURING AN INCOMING INSPECTION FOREIGN MATTER WAS IDENTIFIED WITHIN TEN STATLOCK POUCHES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL TEN DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145008 ↗MalfunctionAug 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INCOMING INSPECTION ON JULY 16, 2025, 1 POUCH CONTAINED A HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841919 ↗MalfunctionOct 18, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED BY THE CUSTOMER, ON (B)(6) 2024 DURING INCOMING INSPECTION IT WAS IDENTIFIED THAT ONE STATLOCK POUCH IS UNSEALED AND THE COMPONENTS ARE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482126 ↗
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.