The Recall Desk
HighFDA (Devices)·Z-1398-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling 3,442 units of 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 FDA classified this as a Class II recall. The hazard involves a missing critical component (implant coil) in a medical device used for neurovascular procedures, which poses a risk of harm if the device is used as intended, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

MicroVention, Inc. is recalling 3,442 units of the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10. 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 affected products were distributed outside the United States to 41 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. The recall covers specific catalog and lot numbers associated with REF numbers 100202CSSR-V through 101036CSSR-V.

Healthcare providers and facilities that have received these products should stop using them and contact MicroVention, Inc. for further instructions. The FDA has classified this as a Class II recall, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled product

Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V,
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
3,442

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: 100202CSSR-V - 1903155ZC
  • 1903185UC
  • 1903225UC
  • 1904085UC
  • 1904225NC
  • 1905155ZC
  • 1905205UC
  • 1905205ZC
  • 1905225UC
  • 1903015WC
  • 1903045WC
  • 1903065WC
  • 1903085WC
  • 1904015WC
  • 1904175WC
  • 1904225WC
  • 1904245WC
  • 1904265WC
  • 1905065WC
  • 1905085WC

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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