The Recall Desk
HighFDA (Devices)·Z-1397-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recall for Missing Implant Coils

MicroVention is recalling 169 units of Microplex 18 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 involves a medical device where a critical component (the implant coil) may be missing, creating a risk of harm if the device is used for its intended purpose, but no injuries or illnesses have been reported.

Plain-English summary

MicroVention, Inc. is recalling 169 units of the MicroVention Terumo Microplex 18, Platinum Coil System. The recall is being conducted because the devices may be missing the implant coil. The affected products 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 affected products include REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Specific catalog and lot numbers are listed in the structured product information. All distribution of the affected units was outside the United States (OUS), with shipments sent to various 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 facilities that have received these devices should stop using them and contact MicroVention, Inc. for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood v
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
169

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: 180204HC-S-V - 1903185WE and 1905105WE
  • 180208HC-S-V - 1904175PE
  • 1904175WE
  • 1904225WE
  • 1904265WE
  • 1904295WE
  • 1905025WE
  • 1905065PE
  • 1905065WE
  • 1905085WE
  • 1905175WE
  • 1905225WE
  • 180308HC-S-V - 1904225WE
  • and 1905035WE
  • 180410HC-S-V - 1903185WE
  • 1904015PE
  • and 1905175WE
  • and 180512HC-S-V - 1903185WE
  • 1905085PE
  • 1905155PE

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

Same manufacturer · Microvention, Inc.

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Same hazard · missing component

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