Reported Mar 4, 2020 · Terminated
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx,…
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 18Platinum Coil SystemEndovascular Embolization CoilHelical 18 SoftSterileRxREF numbers 180204HC-S-V180208HC-S-V180308HC-S-V180410HC-S-Vand 180512HC-S-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
- Lot codes and dates
- Catalog/lot numbers
180204HC-S-V - 1903185WE and 1905105WE180208HC-S-V - 1904175PE1904175WE1904225WE1904265WE1904295WE1905025WE1905065PE1905065WE1905085WE1905175WE1905225WE180308HC-S-V - 1904225WE1904265WE1905025WEand 1905035WE180410HC-S-V - 1903185WE1904015PE1904265WE1904295WE1905085WEand 1905175WEand 180512HC-S-V - 1903185WE1904265WE1904295WE1905085PE1905085WE1905155PE1905155WEand 1905225WE
- Catalog/lot numbers
- Amount recalled
- 169 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.
Want the full recall guide?
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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