Azur Pushable Helical 45-251020Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
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 00810170017452), received between Apr 3, 2020 and Apr 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE LABELS ON THE OUTER BOX AND THE STERILE PACKAGING CONTAINING THE PRODUCT INDICATED THE COIL SIZE WAS 10MM X 20CM; HOWEVER, THE PLASTIC TAB ON THE END OF THE COIL DISPENSER INDICATED THE COIL SIZE WAS 16MM X 20CM. THE COIL WAS INITIALLY INSERTED INTO THE MICROCATHETER, BUT REMOVED BEFORE IT WAS PLACED INTO THE PATIENT'S ANATOMY, AS THE COIL SIZE WAS QUESTIONABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9925604 ↗
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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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