Statlock IV IV0563PRecalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select Macro 6in for low pressure power injectors with SmartSite 25 box · Class 2
Data updated Oct 13, 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 00801741082030), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Misassembled1
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.
MalfunctionAug 27, 2021Break; Misassembled; Break; Misassembled
IT WAS REPORTED "PER CRITICAL CARE HCP: THE EXTENSION PIECE BROKE FROM THE LUER LOCK ENDING AND DISCONNECTED FROM THE PATIENT¿S IV CATHETER HUB PORTION." ADD INFO RCVD: DATE OF OCCURRENCE: AUGUST 1ST. PLACEMENT DATE: (B)(6) 2021. EXPLANT DATE: WE REMOVED AFTER THE TUBING BROKE IN (B)(6) 2021. WAS THERE ANY BLOOD EXPOSURE: LINGERING BLOOD IN THE TUBING AND MINIMAL AT THE INSERTION SITE. WAS THERE PATIENT HARM REPORTED?: NONE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12377363 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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