Azur Detachable Helical HydroCoil 45-481215Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
All models of Azur Detachable Helical HydroCoil (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170018022), received between Sep 27, 2018 and Sep 27, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Migration2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2018Migration; Migration
IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7916755 ↗InjurySep 27, 2018Migration; Migration
IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7916750 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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