Terumo AZUR Peripheral Coil System recall
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.
Why was Terumo AZUR Peripheral Coil System recalled?
The devices may be missing the implant coil.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- 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.
- Recalling firm
- Microvention, Inc.
- Quantity
- 392 units
- 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.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)