Statlock IV Select Start Kit IVK0124Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select Macro 6in with SmartSite Start Kit 50 box · 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
- 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 00801741082498), received between Nov 7, 2018 and Nov 7, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Crack3
- Leak/Splash2
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2018Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8047665 ↗MalfunctionNov 7, 2018Crack; Leak/Splash
IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8047663 ↗MalfunctionNov 7, 2018Crack; Leak/Splash
IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8047639 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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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