Statlock IV Select Start Kit IVK0136Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select Macrobore 6in with SmartSite IV Start Kit · Class 2
All models of Statlock IV Select Start Kit (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741082542), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Fluid/Blood Leak
IT WAS REPORTED THE HUB ON THE EXTENSION TO THE CATHETER IS COMING UNDONE PRETTY EASILY. IT¿S DISCONNECTING FROM THE IV FLUID, AND IN CT THE PRESSURE IS ACTUALLY BLOWING THE HUB OFF THE CONNECTOR AND SPRAYING CONTRAST EVERYWHERE. THEY MENTIONED THIS HAS BEEN HAPPENING FOR THE PAST FEW MONTHS. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107971 ↗
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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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