The Recall Desk
HighFDA (Devices)·Z-1394-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention is recalling 486 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 involves a medical device with a significant functional defect (missing implant coil) that could lead to treatment failure or harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

MicroVention, Inc. is recalling 486 units of the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular. The recall is being conducted 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, and for arterial and venous embolizations in the peripheral vasculature.

The affected units are identified by specific reference numbers, including 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V, 100930HCSR-R-V, 101030HC-R-V, and 101030HCSR-R-V. The distribution was entirely outside the United States, with affected product shipped to 42 countries including Albania, Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, and the United Kingdom.

Healthcare providers and patients should check their inventory and records for these specific reference and lot numbers. If the device is found to be missing the implant coil, it should not be used. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
486

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: 100515HC-R-V - 1903135RL
  • 1905135RL
  • 1903115LL
  • 1903135LL
  • 1903155LL
  • 1903225LL
  • 1904015LL
  • 1904175LL
  • 1905025LL
  • 1905035LL
  • 1905065LL
  • and 1905085LL
  • 100515HCSR-R-V - 1903225UL
  • 1904245UL
  • 1903045WL
  • 1903115WL
  • 1904015PL
  • 1904225WL
  • 1905065WL
  • and 1905225WL

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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