The Recall Desk
HighFDA (Devices)·Z-1404-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coils

MicroVention is recalling 85 units of Microplex 10 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 a critical component (the implant coil) may be missing, posing a risk of harm if the device is used, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

MicroVention, Inc. is recalling 85 units of the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10. The recall was initiated because 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 recall covers specific catalog and lot numbers, including 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. All distribution of the affected product was outside the United States (OUS), with shipments sent to 40 countries including Albania, Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, and the United Kingdom.

Healthcare providers and distributors should check their inventory for the affected lot numbers and stop using the devices. Patients who have already received an implant should contact their healthcare provider for guidance.

The recalled product

Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also inten
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
85

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 (10)

  • Catalog/lot numbers: 100203CMSR-V - 1903085WP
  • 100408CMSR-V - 1903085WP and 1904015PP
  • 100412CMSR-V - 1904225RP
  • 1905205QP
  • and 1904035PP
  • 100510CMSR-V - 1905205QP and 1904085WP
  • 100516CMSR-V - 1903135WP and 1905155WP
  • 100612CMSR-V - 1903225WP
  • 100618CMSR-V - 1903135QP and 1904085WP
  • and 100721CMSR-V - 1903085RP.

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 →

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