High FDA (Devices)·Z-1399-2020·Announced 2020-03-04

MicroVention Platinum Embolization Coils Recalled for Missing Implant Coil

MicroVention is recalling 403 units of Platinum Embolization Coils 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, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

MicroVention, Inc. is recalling 403 units of MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx devices. The recall is due to a defect where the devices may be missing the implant coil. The affected products are identified by specific REF numbers and catalog/lot numbers listed in the official recall notice.

The distribution of the affected products 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 check their inventory and records for the specific REF and lot numbers listed in the recall. If the product is found, it should be removed from use and returned to MicroVention, Inc. according to the instructions provided by the manufacturer.

The recalled product

Product: MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Produc
Manufacturer: Microvention, Inc.
Category: Medical Device — Neurovascular Embolization
Hazard: missing-component
Affected units: 403

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: 180619CS-V - 1903065W1
1904015P1
1904225W1
1904295W1
1905085P1
1905085W1
1905175W1
and 1905205W1
180723CS-V - 1903085W1
1903185W1
1904175P1
and 1905175W1
180827CS-V - 1903205W1
1905155W1
180931CS-V - 1904225R1
1903205W1
and 1905225W1
181036CS-V - 1904035R1
1903085W1
1904265W1

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