Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF num...
FDA Device Recall #Z-1220-2020 — Class II — November 24, 2019
Recall Summary
| Recall Number | Z-1220-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 24, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Microvention, Inc. |
| Location | Aliso Viejo, CA |
| Product Type | Devices |
| Quantity | 445 units |
Product 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.
Reason for Recall
The devices may be missing the implant coil.
Distribution Pattern
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 Information
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.
Other Recalls from Microvention, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1225-2020 | Class II | Terumo AZUR CX Peripheral Coil System, Detachab... | Nov 24, 2019 |
| Z-1222-2020 | Class II | Terumo AZUR CX Peripheral Coil System, Detachab... | Nov 24, 2019 |
| Z-1223-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable ... | Nov 24, 2019 |
| Z-1224-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable ... | Nov 24, 2019 |
| Z-1221-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable ... | Nov 24, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.