Statlock IV IV0563Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select macro 6in SmartSite 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741082016), received between Feb 12, 2020 and Feb 2, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Most reported problems
Device problems
- Disconnection1
- Fluid/Blood Leak1
- Leak/Splash1
- Loose or Intermittent Connection1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2021Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE ITEM LEAKS AND DOES NOT LOCK PROPERLY, STATES LUER LOCK COMES OFF AT TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11269234 ↗MalfunctionSep 3, 2020Disconnection; Disconnection
IT WAS REPORTED "IV0525 (STATLOCK), WE¿VE BEEN ORDERING THIS ITEM AS SUB/ALTERNATE SINCE BEGINNING OF (B)(6) 2020. WE¿VE BEEN USING A MICROCLAVE ITEM# MC100 FOR THE NEEDLESS CONNECTOR END. RECENTLY, WE¿VE HAD A HANDFUL OF ACCOUNTS WHERE CONNECTIONS HAVE BECOME DISCONNECTED. NURSING STAFF REPORTED MAKING SURE ALL CONNECTIONS ARE SECURE, BUT WE CONTINUE TO EXPERIENCE DISCONNECTS. IT HAS BEEN NOTED THAT THE I.V TUBING WITH FLUID IS LOOSE / DISCONNECTING FROM THE PERIPHERAL I.V EXTENSION , WHICH HAS THE MICROCLAVE ATTACHED TO IT. IT IS NOT LEAKING OR RELATED TO ANY PRESSURE ISSUES. IT JUST SEEMS TO ¿ UNWIND ¿. WE DID NOT KEEP ANY OF THE AFFECTED LINES. I DO NOT HAVE A CONFIRMED NUMBER OF HOW MANY TIMES THIS WAS NOTED. THIS WAS REPORTED BY AN RN , AND AN ANESTHESIOLOGIST, THAT THEY NOTICED THE CONNECTIONS WERE LOOSE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10491429 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A CRACK AT THE CONNECTION OF THE VALVE AND TUBING RESULTING IN BACKFLOW OF BLOOD ONTO PATIENT BED AND CLOTING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9701461 ↗
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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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