Azur Pushable Helical 45-251014Recalls & 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 00810170012556), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Ischemia1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2020Migration; Migration
IT WAS REPORTED THAT PERIPHERAL COIL EMBOLIZATION WAS PERFORMED FOR A SPLENIC ARTERY ANEURYSM. POST-DEPLOYMENT IMAGES DEMONSTRATED MIGRATION OF AN EMBOLIZATION COIL TO THE SPLENIC HILUM. THE PATIENT EXPERIENCED INCREASING PAIN OVER THE FOLLOWING TWO WEEKS, WHICH WAS MANAGED WITH MEDICATIONS. SUBSEQUENT CT IMAGING TAKEN 17 DAYS POST-PROCEDURE DEMONSTRATED SEGMENTAL SPLENIC INFARCTION. THE PATIENT'S CURRENT STATUS HAS NOT BEEN PROVIDED.
Patient problems: Ischemia; Pain
MAUDE report 10752776 ↗
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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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