Reported Mar 4, 2020 · Terminated
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers…
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 MicroplexPlatinum Coil SystemEndovascular Embolization CoilVFCSterileRxREF numbers MV-00306VFCMV-00315VFCMV-00310VFCMV-00630VFCVFC010303-VVFC030606-VVFC030610-VVFC030615-VVFC061020-VVFC061030-VVFC101530-VVFC101540-VVFC152040-Vand VFC152060-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
109 of 109 codes
MV-00306VFC - 1904105NZ and 1905085NZMV-00310VFC - 1903045TZ1904035TZ1904085NZAND 1905065NZMV-00315VFC - 1903045TZ1903155NZand 1904055YVMV-00630VFC - 1904085FV and 1905085FVVFC010303-V - 1903065WV1904015WV1904105WV1904155WV1904175WV1904225WV1904245WV1904265WV1905065WV1905105WV1905155WVand 1905175WVVFC030606-V - 1903045WV1903065WV1903085PV1903205WV1904015WV1904035WV1904055WV1904105WV1904155PV1904175UV1904175WV1904225WV1904245UV1904245WV1904265WV1905065WVand 1905175WVVFC030610-V - 1903015WV1903065WV1904015WV1904035WV1904055WV1904155WV1904175UV1904175WV1904225UV1904225WV1904245UV1904245WV1904265WV1905065WV1905085WV1905105WV1905135WV1905155PV1905175WVand 1905225WVVFC030615-V - 1903015WV1903045WV
- Catalog/lot numbers
- Amount recalled
- 666 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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