MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 19 units of the Microplex 18 Platinum Coil System 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 involves a high-risk medical device where a critical component (the implant coil) may be missing, creating a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
MicroVention, Inc. is recalling 19 units of the MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18. The recall is due to a defect where 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 specific reference numbers involved are 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V.
All 19 units were distributed outside of the United States to various countries including Albania, Austria, Belarus, Belgium, Brazil, and others. The source text does not specify any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within t
- Manufacturer
- Microvention, Inc.
- Hazard
- Affected units
- 19
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 (9)
- Catalog/lot numbers: 180512CC-V - 1905205W3
- 180820CC-V - 1903115L3
- 181026CC-V - 1903115L3
- 181434CC-V - 1903115L3
- 1905155W3
- and 1905205R3
- and 182050CC-V - 1905205W3
- 1903115L3
- and 1905205R3.
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.
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