Reported Mar 4, 2020 · Terminated

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile,…

Microvention, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601

- 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
- 100930HCSR-R-V
- 101030HC-R-V
- and 101030HCSR-R-V
Product UsageThe MCS is also 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 firm name on the label is MicroVention, Inc., Tustin, CA

Lot codes and dates: 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
100520HC-R-V - 1905175LL
1905205LL
1905205VL
100520HCSR-R-V - 1904245UL
1904295UL
and 1903085WL
100620HC-R-V - 1903115LL
1905035LL
and 1905065LL
100620HCSR-R-V - 1904245UL
100730HC-R-V - 1905155LL
1905175LL
and 1905225LL
100730HCSR-R-V - 1904175PL
1904225WL
and 1905035WL
100830HC-R-V - 1905135RL
1905135LL
and 1905175LL
100930HC-R-V - 1903115LL
100930HCSR-R-V - 1903085ZL
1903115UL
1903135UL
and 1904245UL
101030HC-R-V - 1903135RL
and 101030HCSR-R-V - 1904245UL and 1903015RL
Amount recalled: 486 units

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

The devices may be missing the implant coil.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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