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.
This recall has been terminated (originally issued November 24, 2019).
- Company
- Microvention Inc.
- Recall Initiated
- November 24, 2019
- Terminated
- April 20, 2021
- Recall Number
- Z-1223-2020
- Quantity
- 392 units
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).