Reported Mar 4, 2020 · Terminated

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, 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 10
- Platinum Coil System
- Endovascular Embolization Coil
- HyperSoft 3D
- Sterile
- Rx
- REF numbers 100102HS3D-V
- 100103HS3D-V
- 100152HS3D-V
- 100153HS3D-V
- 100154HS3D-V
- 100202HS3D-V
- 100203HS3D-V
- 100204HS3D-V
- 100206HS3D-V
- 100208HS3D-V
- 100254HS3D-V
- 100256HS3D-V
- 100304HS3D-V
- 100306HS3D-V
- 100310HS3D-V
- 100355HS3D-V
- 100358HS3D-V
- 100406HS3D-V
- 100408HS3D-V
- 100412HS3D-V
- 100415HS3D-V
- 100510HS3D-V
- 100515HS3D-V
- MV-00102HTDA
- MV-00103HTDA
- MV-00204HTDA
- MV-00304HTDA
- MV-00306HTDA
- MV-00406HTDA
- MV-00408HTDA
- MV-00510HTDA
- MV-01502HTDA
- MV-01503HTDA
- MV-01504HTDA
- MV-02504HTDA
- MV-02506HTDA
- MV-03505HTDA
- and MV-03508HTDA
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
287 of 287 codes
100102HS3D-V - 1903045WT
1903065WT
1903205WT
1904015WT
1904035WT
1904245WT
1904255WT
1904265WT
1904295WT
1905025WT
1905065WT
1905085WT
1905155WT
1905175WT
and 1905205WT
100103HS3D-V - 1903115TT
1903015WT
1903085WT
1903135WT
1904015WT
1904035WT
1904055WT
1904105WT
1904265WT
1904295WT
1905035WT
1905105PT
1905135WT
1905155WT
and 1905225WT
100152HS3D-V - 1903065NT
1903045WT
1903085WT
1903205WT
1903225WT
1904015WT
1904105WT
1904175WT
1904295WT
1905025WT
1905105WT
1905135WT
1905155WT
and 1905175WT
100153HS3D-V - 1903015WT
1903045WT
1903065WT
1903155WT
1904015WT
1904035WT
1904265WT
1904295WT
1905135WT
and 1905205WT
100154HS3D-V - 1903045WT
1903085WT
1903135WT
1903185WT
1903225WT
1904015WT
Amount recalled: 1,725 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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