Statlock IV IV0221Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Plus Trapezoidal pad, clamshell retainer, macro bore 6in Luer lock extension set 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741081699), received between Jun 19, 2020 and Jun 19, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 Leak4
- Detachment of Device or Device Component2
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING PART OF THE STATLOCK IV PLUS HAS BEEN BREAKING. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS ADDRESSES THE THIRD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10175379 ↗MalfunctionJun 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING PART OF THE STATLOCK IV PLUS HAS BEEN BREAKING . ONE OF THE PATIENT HAS DEVELOPED A BLOOD STREAM INFECTION THAT A LINE BREAK COULD BE CONTRIBUTED TO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10175374 ↗MalfunctionJun 19, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THE TUBING PART OF THE STATLOCK IV PLUS HAS BEEN BREAKING. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS ADDRESSES THE SECOND.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10175291 ↗MalfunctionJun 19, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THE TUBING PART OF THE STATLOCK IV PLUS HAS BEEN BREAKING. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS ADDRESSES THE FIRST.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10175288 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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