CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
Terumo AZUR Peripheral Coil System, Detachable recalled by Microvention
Microvention is recalling Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, distributed in Maryland. The recall was initiated on 24 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1223-2020
- FDA event ID
- 84585
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Nov 2019
- FDA classified
- 13 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Nov 2019 | Recall initiated by company | |
| 13 Feb 2020 | Classified by FDA | +81 days |
| 19 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices may be missing the implant coil.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System recalled?
Yes. Microvention recalled Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System on 24 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-1223-2020.
Why was it recalled?
The devices may be missing the implant coil.
Which lots are affected?
Catalog/lot numbers: 45-451015 - 190410589; 45-451020- 19030456J, 19041056C, 19041756Y, 190422549, and 190422573; 45-451215 -190410569; 45-451220 -19040853N; 45-451230 -19041554R; 45-451520 -19030654N, 190408565, 190410588, and 190422572; 45-451530 -19030456L, 190408569, 19041056A, 190415571, 19041756Z, 190417599, 19042656G, and 19050254X; 45-452020 -19030456N, 19030654L, 19030655W, 19040856A, and 19041552H; 45-452030 - 19041058A, 19041554U, and 19042656H; 45-450410 - 19030456C, 19030655V, 19041058F, and 190422575; 45-450415 - 190422574; 45-450405 - 19030453C, 19030456B, and 19042254B; 45-450610 - 19030456E, 19030654W, 190410568, and 19041058E; 45-450615 - 19030456F, 190401568, 19041058C, and 19041556Y; 45-450620 - 19030453J and 19030655N; 45-450815 - 19030456G, 19030654U, 19050253U, and 19050254Z; 45-450820 - 19030453K,19030456H, 19030654R, 19030655G, 19030655H, 19050253V, 19050254Y, 19050657T, and 19051058C; and MV-AZ52030HD - 190405564.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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