High FDA (Devices)·Z-1400-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling Microplex 10 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 the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10. The recall involves 409 units of the sterile, prescription-only medical device. The specific reason for the recall is that the devices may be missing the implant coil.

The affected product is 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 covers specific REF numbers including 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V.

All distribution of the affected product was 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 recall.

The recalled product

Product: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended
Manufacturer: Microvention, Inc.
Category: Medical Device — Endovascular Embolization Coil
Hazard: missing-component
Affected units: 409

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: 100204CC-V -1905085LX
1905175LX
1905205LX
1903185WX
1903205WX
1904225WX
1904245WX
1904265WX
and 1904295WX
100307CC-V - 1903205WX
1904015WX
and 1905225WX
100410CC-V - 1904015WX
1904175PX
1904175WX
1905025WX
1905065WX
1905155WX
1905205WX
and 1904035QX

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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Same hazard · missing component