Reported Mar 4, 2020 · Terminated

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF…

Microvention, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601

- MicroVention Terumo Microplex 18
- Platinum Coil System
- Endovascular Embolization Coil
- Complex 18
- Sterile
- Rx
- REF numbers 180512CC-V
- 180820CC-V
- 181026CC-V
- 181434CC-V
- and 182050CC-V
Product UsageThe MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA

Lot codes and dates: Catalog/lot numbers
180512CC-V - 1905205W3
180820CC-V - 1903115L3
181026CC-V - 1903115L3
181434CC-V - 1903115L3
1905155W3
and 1905205R3
and 182050CC-V - 1905205W3
1903115L3
1903115L3
1903115L3
1905155W3
and 1905205R3
Amount recalled: 19 units

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

The devices may be missing the implant coil.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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