# FDA recall Z-1223-2020

> **Microvention, Inc.** · Class II · device recall initiated 2019-11-24.

## Product

Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System,  REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx.  The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

## Reason for recall

The devices may be missing the implant coil.

## Distribution

The devices were distributed to Maryland.  There was no direct military/government distribution.  Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

## Key facts

- **Recall number:** Z-1223-2020
- **Recalling firm:** Microvention, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-24
- **Report date:** 2020-02-19
- **Termination date:** 2021-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2020

## Citation

> AI Analytics. FDA recall Z-1223-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1223-2020. Source: US FDA. Licensed CC0.

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