Statlock IV IV0521CERecalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select Luer retainer, Select pads, micro 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
- 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 00801741081842), received between Oct 22, 2021 and Oct 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Misconnection” (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
- Misconnection1
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.
MalfunctionOct 22, 2021Misconnection; Misconnection
IT WAS REPORTED THAT (B)(6) PATIENT HOSPITALIZED FOR RIGHT KNEE PROSTHESIS INFECTION. THE PATIENT IS INFUSED ON A MIDLINE, WHICH HAD BEEN PLACED ON (B)(6). A NON-OCCLUSIVE DRESSING IS PLACED OVER THE MIDLINE DUE TO A DISCHARGE BLOODY AT THE OPENING. THE DRESSING IS REMOVED BECAUSE THE STATLOCK IS TAKEN OFF. IT IS THEN FOUND THAT THE MIDLINE IS EMERGED BY 5 CM. DURING THE REPAIR OF THE DRESSING WITH THE KIT PROVIDED, DIFFICULTY TO CLOSE THE NEW STATLOCK. THE LINE CAME OUT 5 CM AGAIN DURING HANDLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12685371 ↗
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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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