Azur Pushable Helical 45-280606Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170012228), received between Jan 23, 2020 and Jan 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
Patient problems
- No Code Available1
- Therapeutic Response, Decreased1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A GASTRODUODENAL ARTERY (GDA) BLEED. THE AZUR PUSHABLE COIL DID NOT FORM IN THE GDA. TWO SUBSEQUENT COILS WERE SUCCESSFULLY DEPLOYED IN THE TREATMENT SITE WITHOUT ANY ISSUES. THE PUSHABLE COIL WAS UNABLE TO BE REMOVED OR REPOSITIONED. THE COILS DID NOT STOP THE BLEEDING. A LAPAROTOMY WAS THEN PERFORMED TO TREAT THE INITIAL GDA BLEED.
Patient problems: No Code Available; Therapeutic Response, Decreased
MAUDE report 9625001 ↗
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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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