The Recall Desk
HighFDA (Devices)·Z-1396-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling 9 units of Microplex 18 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 high-risk medical device where the primary implant component may be missing, creating a risk of harm if used, but the source text does not report any injuries or illnesses.

Plain-English summary

MicroVention, Inc. is recalling 9 units of the MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular. The specific reference numbers affected are 180520HC-R-V and 181230HC-R-V. These sterile, prescription-only devices are 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 was initiated because the devices may be missing the implant coil. The source text does not report any illnesses, injuries, or deaths associated with this recall.

The affected units were distributed outside of the United States to 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 facilities in these regions should verify their inventory against the specific catalog and lot numbers 180520HC-R-V (1903135RE) and 181230HC-R-V (1903085RE) and contact MicroVention, Inc. for further instructions.

The recalled product

Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
9

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 (2)

  • Catalog/lot numbers: 180520HC-R-V - 1903135RE
  • and 181230HC-R-V - 1903085RE.

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 →

Related recalls

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Same hazard · missing component

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