Statlock IV IV0572Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select macro 6in ULTRASITE 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00801741082115), received between Dec 23, 2019 and Sep 29, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak6
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE IV STAT LOCK MALFUNCTIONING WHERE THE TUBING SPLIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505349 ↗MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE IV STAT LOCK MALFUNCTIONED." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15499510 ↗MalfunctionSep 28, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED " FLUID LEAKED FROM A CRACK IN THE HUB."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15499396 ↗MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "SMALL CRACK/HOLE IN STATLOCK IV EXTENSION SET CAUSING PATIENT'S BLOOD TO SPRAY OUT OF SIDE OF TUBING CAUSING PATIENT BLOOD LOSS, DISTRESS AND STAINING PATIENT'S CLOTHING WITH BLOOD."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14317716 ↗MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV TUBING CAP WOULD NOT TIGHTEN WHICH CAUSED LEAKING. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513431 ↗MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV TUBING CAP WOULD NOT TIGHTEN WHICH CAUSED LEAKING. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513405 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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