Azur Detachable Framing Coil 45-650820Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
All models of Azur Detachable Framing Coil (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170016097), received between Nov 8, 2016 and Aug 24, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component2
- Device-Device Incompatibility1
- Difficult to Advance1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF AN EMBOLIZATION COIL IN THE MICROCATHETER. THE COIL WAS THEN "PUSHED HARD" TO ADVANCE THE COIL, AND THE COIL UNEXPECTEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6819652 ↗MalfunctionNov 8, 2016Detachment Of Device Component; Difficult to Advance; Detachment Of Device Component; Difficult to Advance
IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A SPLENIC ANEURYSM EMBOLIZATION. PHYSICIAN HAD A 6 FR COOK RAABE GUIDING SHEATH IN THE SPLENIC ARTERY. HE ADVANCED A TERUMO GLIDECATHETER (NON-TAPERED ANGEL) INTO THE ANEURYSM. WHEN ADVANCING THE 20 X 50 FRAMER THROUGH THE GLIDECATHETER, IT GOT STUCK AT THE END OF THE CATHETER AND WOULD NOT ADVANCE. WHEN PULLING BACK ON THE PUSHER WIRE, THE COIL DETACHED IN THE GLIDECATHETER. THE GLIDECATHETER WAS REMOVED WITH THE COIL INSIDE. THE COIL WAS DISCARDED AND NOT IMPLANTED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6087903 ↗
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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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