High FDA (Devices)·Z-1406-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling 666 units of Platinum Coil Systems because the implant coil may be missing from the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a missing critical component in a medical device used for vascular occlusion, representing a risk of harm where injury has not yet been reported.

Plain-English summary

MicroVention, Inc. is recalling 666 units of the MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC. The recall is being conducted because the devices may be missing the implant coil.

The affected products are sterile, prescription-only medical devices intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation, as well as for arterial and venous embolizations in the peripheral vasculature. The recall includes specific reference numbers such as MV-00306VFC, MV-00315VFC, and various VFC series models.

Distribution of the affected units was entirely outside the United States (OUS). The countries receiving the affected product include Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, 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. Healthcare providers and patients should contact MicroVention, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product: 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, VFC1520
Manufacturer: Microvention, Inc.
Category: Medical Device — Endovascular Embolization Coil
Hazard: missing-component
Affected units: 666

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 16 recalled by Microvention, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

Same manufacturer · Microvention, Inc.

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