High FDA (Devices)·Z-1407-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recall for Missing Implant Coils

MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.

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 involves a Class II medical device where the implant coil may be missing, creating a risk of harm during a procedure, but no injuries or illnesses are reported in the source text.

Plain-English summary

MicroVention, Inc. is recalling the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile. The recall involves 5,777 units of the device, which 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 reason for the recall is that the devices may be missing the implant coil. The affected product was distributed outside the United States to 42 countries, including 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 who have received these specific devices should contact MicroVention, Inc. for further instructions. The recall number is Z-1407-2020.

The recalled product

Product: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100
Manufacturer: Microvention, Inc.
Category: Medical Device — Endovascular Embolization Coil
Hazard: missing-component
Affected units: 5,777

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: 100101HS-V - 1903045UH
1903065UH
1903115UH
1903135UH
1903155UH
1903185UH
1903205UH
1903225UH
1903225ZH
1904085UH
1904105UH
1904175UH
1904245UH
1905025UH
1905085UH
1905105ZH
1905135UH
1905175UH
1905205UH
1905205ZH

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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