Statlock IV Select Start Kit IVK0177Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select Macrobore 6in IV 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
- 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 00801741082665), received between Mar 25, 2020 and May 28, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
- Detachment of Device or Device Component5
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED IV INITIATED ON (B)(6) 2020, ON (B)(6) 2020 THE IV J-LOOP TUBING BROKE FROM HUB. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10096321 ↗MalfunctionMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED "YESTERDAY AFTERNOON I HAD A PATIENT'S J LOOP ATTACHED TO THE IV CATHETER COME OUT FROM THE PLASTIC ATTACHMENT. IT WAS ATTACHED AT THE SITE WHERE THE STAT LOCK IS SO THE PATIENT COULDN'T HAVE INADVERTENTLY PULLED IT OUT".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10050006 ↗MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FOURTH OF FOUR DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880375 ↗MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD OF FOUR DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880374 ↗MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF FOUR DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880369 ↗MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF FOUR DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880368 ↗
Other Set, administration, intravascular devices
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- 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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