Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL, MV-AZ80310HL, MV-AZ80410HL, MV-AZ80420HL, MV-AZ80620HL, MV-AZ80820HL, and MV-AZ81020HL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog/lot numbers: 45-481015 - 19031155A; 45-481020 - 19031355E and 190424567; 45-481215 - 19031154K and 19041554Z; 45-481220 - 19051357G; 45-481515 - 19041554W and 19041556Q; 45-481520 - 19032053A; 45-482020 - 190320539 and 19040855Y; 45-482030 - 19040855X; 45-480202 - 19032054J and 190506581; 45-480204 - 19051357N; 45-480310 - 19031154N, 19031355G, 190401554, and 19050657X; 45-480302 - 19050657V and 19051357P; 45-480305 - 19031154L, 19031354G, 19031355F, 19042254K, 19042453J, 19050657W, and 19051357L; 45-480410 - 19031154G,19031155B, 19031354H, 19031355H, 19032054N, 190415553, 19042254L, and 19051357K; 45-480415 - 19041554V and 19050657U; 45-480420 - 190506582 and 19051357H; 45-480405 - 190424568; 45-480610 - 19041554Y, 19041556V, and 19051357J; 45-480615 - 19042254G; 45-480620 - 19031354J, 19041554X, and 19042453K; 45-480815 - 19040853U and 190415552; 45-480820 - 19031355J,19032053C, and 19032252U; MV-AZ80520HL - 190401556, 190401566, and 19040554H; MV-AZ80202HL - 190517542 and 190517566; MV-AZ80204HL - 19051756C; MV-AZ80305HL - 190517543; MV-AZ80310HL - 190517544; MV-AZ80410HL - 19040554J and 19040555X; MV-AZ80420HL - 19050253Y, 19050254W, 190517545, and 190517569; MV-AZ80620HL - 19050254V and 190517546; MV-AZ80820HL - 19051756A; and MV-AZ81020HL - 190517564.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Microvention, Inc.
- Reason for Recall:
- The devices may be missing the implant coil.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL, MV-AZ80310HL, MV-AZ80410HL, MV-AZ80420HL, MV-AZ80620HL, MV-AZ80820HL, and MV-AZ81020HL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Product Codes/Lot Numbers:
Catalog/lot numbers: 45-481015 - 19031155A; 45-481020 - 19031355E and 190424567; 45-481215 - 19031154K and 19041554Z; 45-481220 - 19051357G; 45-481515 - 19041554W and 19041556Q; 45-481520 - 19032053A; 45-482020 - 190320539 and 19040855Y; 45-482030 - 19040855X; 45-480202 - 19032054J and 190506581; 45-480204 - 19051357N; 45-480310 - 19031154N, 19031355G, 190401554, and 19050657X; 45-480302 - 19050657V and 19051357P; 45-480305 - 19031154L, 19031354G, 19031355F, 19042254K, 19042453J, 19050657W, and 19051357L; 45-480410 - 19031154G,19031155B, 19031354H, 19031355H, 19032054N, 190415553, 19042254L, and 19051357K; 45-480415 - 19041554V and 19050657U; 45-480420 - 190506582 and 19051357H; 45-480405 - 190424568; 45-480610 - 19041554Y, 19041556V, and 19051357J; 45-480615 - 19042254G; 45-480620 - 19031354J, 19041554X, and 19042453K; 45-480815 - 19040853U and 190415552; 45-480820 - 19031355J,19032053C, and 19032252U; MV-AZ80520HL - 190401556, 190401566, and 19040554H; MV-AZ80202HL - 190517542 and 190517566; MV-AZ80204HL - 19051756C; MV-AZ80305HL - 190517543; MV-AZ80310HL - 190517544; MV-AZ80410HL - 19040554J and 19040555X; MV-AZ80420HL - 19050253Y, 19050254W, 190517545, and 190517569; MV-AZ80620HL - 19050254V and 190517546; MV-AZ80820HL - 19051756A; and MV-AZ81020HL - 190517564.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1220-2020
Related Recalls
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MICROVENTION
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