Azur Detachable Helical HydroCoil 45-450410Recalls & 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
- 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 00810170014895), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- Chest Tightness/Pressure1
- Vascular System (Circulation), Impaired1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL INTERVENTION DUE TO COIL MIGRATION, TO SURGICALLY REMOVE A PREVIOUSLY IMPLANTED COOK STENT ZILVER OR COIL FRAGMENTS. IN THE AFTERNOON OF (B)(6) 2017, THE PATIENT CALLED THE PHYSICIAN COMPLAINING OF SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PHYSICIAN DIRECTED THE PATIENT TO PRESENT HIMSELF TO THE (B)(6) EMERGENCY ROOM. AT THE EMERGENCY ROOM, DOCTORS PERFORMED A BATTERY OF TESTS AND SCANS. TESTS SHOWED THAT THE COOK BILIARY STENT AND TERUMO AZUR COIL DR. (B)(6) HAD PREVIOUSLY IMPLANTED HAD FAILED. INSTEAD OF STAYING IN PLACE, THE ZILVER STENT AND COIL HAD MOVED AND WERE OBSTRUCTING HIS RIGHT ATRIUM, THE RIGHT-HAND SIDE OF HIS HEART. TO BE SURE, ONE OF THE STENT'S COILS THAT WAS IN HIS PELVIS WAS NOW IN A TERTIARY PULMONARY ARTERY ON THE RIGHT SIDE OF THE PATIENT'S HEART FURTHERMORE, AN X-RAY SHOWED THAT THERE WAS A COIL IN THE PATIENT'S RIGHT LUNG. DR. (B)(6) ELECTED TO REMOVE THE FAILED STENT AND AZUR COIL. THE PATIENT WAS SUBJECTED TO ANESTHESIA AND A LENGTHY PROCEDURE TO REMOVE THE STENT AND COIL DEBRIS. AFTER THE PROCEDURE, THE PATIENT WAS SENT TO THE ICU FOR OBSERVATION. THE FOLLOWING MORNING, A CT SCAN SHOWED THAT THE PHYSIC
Patient problems: Chest Tightness/Pressure; Vascular System (Circulation), Impaired
MAUDE report 8586907 ↗
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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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