CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Terumo Microplex, Platinum Coil System recalled by Microvention
Microvention is recalling Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, distributed in Georgia. The recall was initiated on 22 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1406-2020
- FDA event ID
- 84727
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2019
- FDA classified
- 27 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 22 Nov 2019 | Recall initiated by company | |
| 27 Feb 2020 | Classified by FDA | +97 days |
| 4 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices may be missing the implant coil.
Product as listed by the FDA
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-V. Product Usage: . The 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.
Where it was distributed
All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Questions about this recall
Why was it recalled?
The devices may be missing the implant coil.
Which lots are affected?
Catalog/lot numbers: MV-00306VFC - 1904105NZ and 1905085NZ; MV-00310VFC - 1903045TZ, 1904035TZ, 1904085NZ, AND 1905065NZ; MV-00315VFC - 1903045TZ, 1903155NZ, and 1904055YV; MV-00630VFC - 1904085FV and 1905085FV; VFC010303-V - 1903065WV, 1904015WV, 1904105WV, 1904155WV, 1904175WV, 1904225WV, 1904245WV, 1904265WV, 1905065WV, 1905105WV, 1905155WV, and 1905175WV; VFC030606-V - 1903045WV, 1903065WV, 1903085PV, 1903205WV, 1904015WV, 1904035WV, 1904055WV, 1904105WV, 1904155PV, 1904175UV, 1904175WV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, and 1905175WV; VFC030610-V - 1903015WV, 1903065WV, 1904015WV, 1904035WV, 1904055WV, 1904155WV, 1904175UV, 1904175WV, 1904225UV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, 1905085WV, 1905105WV, 1905135WV, 1905155PV, 1905175WV, and 1905225WV; VFC030615-V - 1903015WV, 1903045WV, 1903065PV, 1903065WV, 1903225UV, 1903225ZV, 1904015WV, 1904055WV, 1904085WV, 1904245WV, 1904265WV, 1905025WV, 1905035WV, 1905085PV, 1905085WV, and 1905175WV; VFC061020-V - 1903045WV, 1903065WV, 1903205WV, 1904225WV, 1904265WV, 1905025WV, 1905065WV, 1905085WV 1905175WV, and 1905225WV; VFC061030-V - 1903065WV, 1904015PV, 1904015WV, 1904055WV, 1904225WV, 1904245WV, 1904265WV, 1905035WV, 1905065PV, and 1903115RV; VFC101530-V - 1903135WV, 1904265WV, 1905025WV, 1905105WV, 1905175WV, and 1905205WV; VFC101540-V - 1903045WV, 1903185WV, 1904265WV, 1905025WV, 1905035WV, and 1905225WV; VFC152040-V - 1903135RV; and VFC152060-V - 1903085RV, 1904265RV, and 1905135RV.
Where was it sold?
All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 84727This product is part of a recall event; the main page for the event is Terumo HydroSoft 10, HydroCoil Embolic System recalled by Microvention.
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