Reported Mar 4, 2020 · Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, 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
Is this the product you have?
MicroVention Terumo Microplex 10Platinum Coil SystemEndovascular Embolization CoilComplex 10SterileRxREF numbers 100204CC-V100307CC-V100410CC-V100512CC-V100615CC-V100718CC-V100820CC-V100924CC-Vand 101026CC-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
68 of 68 codes
100204CC-V -1905085LX1905175LX1905205LX1903185WX1903205WX1904225WX1904245WX1904265WXand 1904295WX100307CC-V - 1903205WX1904015WX1904225WX1904245WX1904265WXand 1905225WX100410CC-V - 1904015WX1904175PX1904175WX1904225WX1904245WX1904265WX1905025WX1905065WX1905155WX1905205WXand 1904035QX100512CC-V - 1903115LX1905205LX1903045WX1903205PX1903205WX1904225WX1905175WX1905205WX1904225RXand 1905135RX100615CC-V - 1903085WX1903205WX1904225WX1904265WX1905105WX1905175WXand 1905225PX100718CC-V - 1903115LX1905175LX1905205LX1903185WX1903205WX1904225WX1904265WX1905105WXand 1905175WX100820CC-V - 1905175LX1904175WX1905025WX1905065PXand 1905135RX100924CC-V - 1905175LX1904175WX1905065PX
- Catalog/lot numbers
- Amount recalled
- 409 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
The devices may be missing the implant coil.
This product could cause temporary or reversible health problems — stop using it.
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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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