AirGuard 5513150Recalls & reported problems
Bard Access Systems, Inc. · AirGuard 15Fx13cm Valved · 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 00801741041594), received between Mar 9, 2017 and Mar 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2017Positioning Problem
IT WAS REPORTED THAT THIS INTRODUCER HAS A CLEAR PLASTIC PIECE THAT IS SUPPOSED TO BE ATTACHED TO THE WHITE WING OF THE INTRODUCER. FACILITY REPORTED THAT THESE TWO PIECES WERE NOT ATTACHED AND BECAUSE OF THAT THE PHYSICIAN REPORTED DIFFICULTY WHEN INTRODUCING IT INTO THE INTERNAL JUGULAR VEIN.
Patient problems: No Information
MAUDE report 6391663 ↗
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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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