The Recall Desk
HighFDA (Devices)·Z-1393-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling 1,725 units of Microplex 10 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 is classified as FDA Class II, and the hazard involves a missing critical component in a medical device used for neurovascular procedures, representing a risk of harm where injury has not yet been reported.

Plain-English summary

MicroVention, Inc. is recalling 1,725 units of the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D. The recall was initiated because the devices may be missing the implant coil.

The affected products are sterile, prescription-only endovascular embolization coils 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 covers specific catalog and lot numbers listed in the official FDA notice.

All distribution of the affected product was 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 distributors in these regions should verify their inventory against the provided lot numbers and contact MicroVention for further instructions.

The recalled product

Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
1,725

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: 100102HS3D-V - 1903045WT
  • 1903065WT
  • 1903205WT
  • 1904015WT
  • 1904035WT
  • 1904245WT
  • 1904255WT
  • 1904265WT
  • 1904295WT
  • 1905025WT
  • 1905065WT
  • 1905085WT
  • 1905155WT
  • 1905175WT
  • and 1905205WT
  • 100103HS3D-V - 1903115TT
  • 1903015WT
  • 1903085WT
  • 1903135WT
  • 1904055WT

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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