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.
- Company
- Microvention Inc.
- Recall Initiated
- November 24, 2019
- Terminated
- April 20, 2021
- Recall Number
- Z-1220-2020
- Quantity
- 445 units
- Firm Location
- Aliso Viejo, CA
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: 45-481015 - 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.
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).