AngioDynamics 91408Recalls & reported problems
Navilyst Medical, Inc. · Namic Inflation Device Kit
All models of AngioDynamics (16)
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 H965914080), received between Aug 28, 2017 and Aug 28, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, ONCE THE INFLATION DEVICE FROM A PROCEDURE KIT WAS FILLED WITH CONTRAST, A HAIR WAS NOTED TO BE "WEDGED IN THE PLUNGER" OF THE DEVICE (I.E., IN THE FLUID PATH). THE EQUIPMENT WAS REMOVED FROM THE TABLE AND WAS NOT USED FOR THE PROCEDURE. IT HAS BEEN INDICATED THAT THE INFLATION DEVICE WILL BE RETURNED TO ANGIODYNAMICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6823700 ↗
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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