Reported Mar 4, 2020 · Terminated

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

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

Is this the product you have?

- MicroVention Terumo Microplex 10
- Platinum Coil System
- Endovascular Embolization Coil
- HyperSoft Helical
- Sterile
- Rx
- REF numbers 100101HS-V
- 100102HS-V
- 100103HS-V
- 100104HS-V
- 100151HS-V
- 100152HS-V
- 100153HS-V
- 100154HS-V
- 100201HS-V
- 100202HS-V
- 100203HS-V
- 100204HS-V
- 100206HS-V
- 100254HS-V
- 100256HS-V
- 100304HS-V
- 100306HS-V
- 100308HS-V
- 100406HS-V
- 100408HS-V
- and 100508HS-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 numbers100101HS-V - 1903045UH, 1903065UH, 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1905025UH, 1905085UH, 1905105ZH, 1905135UH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1903135WH, 1904175WH, 1905085WH, 1905105PH, and 1905135WH; 100102HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1904035WH, and 1905155WH; 100103HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1904105UH, 1904155UH, 1904175UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, and 1905085WH; 100104HS-V - 1903115UH, 1903135UH, 1903225UH, 1904085UH, 1904105UH, 1904155UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1904175WH, 1904225WH, and 1905155WH; 100151HS-V - 1905025UH, 1903135TH, 1903085WH, 1903205WH, 1904015WH, 1904265WH, 1904295WH, 1905085WH, 1905155WH, and 1905225PH; 100152HS-V - 1903155UH, 1903185UH, 1903205UH, 1904085UH, 1904105UH, 1904155UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH. 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205ZH, 1903065NH, 1904175TH, 1904225NH, 1905065NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904085WH, 1904155WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155WH, and 1905225WH; 100153HS-V - 1903225UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1905225UH, 1905225ZH, 1903015NH, 1903065WH, 1903085WH, 1903205WH, 1904015WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225PH, 1904225WH, 1904245WH, 1904265WH, 1905025WH, 1905035PH, 1905065WH, 1905085WH, 1905155WH, 1905205PH, 1905225PH, and 1905225WH. 100154HS-V - 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905225UH, 1903115TH, 1903015WH, 1903045WH, 1903065WH, 1904035WH, 1904055WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155PH, 1905155WH, 1905175WH, and 1905205WH; 100201HS-V - 1903135UH 100202HS-V - 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1904225NH, 1905065NH, 1905205NH, 1903085WH, 1904015WH, 1904055WH, 1904175WH, 1904245WH, 1904265WH, 1904295WH, 1905085WH, 1905225PH, and 1905225WH; 100203HS-V - 1903155UH, 1903185UH, 1903225UH, 1904225NH, 1905135NH, 1903015WH, 1903065WH, 1904035WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035WH, 1905155WH, and 1905225WH; 100204HS-V - 1904085UH, 1904105UH, 1904225UH, 1904245UH, 1905065UH, 1905085UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1903045WH, 1903065WH, 1904015WH, 1904035WH, 1904155WH, 1904175WH, 1904225PH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035WH, 1905085WH, 1905155WH, and 1905225WH; 100206HS-V - 1904085UH, 1904105UH, 1904155UH, 1904175UH, 1904265UH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905175UH, 1905205UH 1905205ZH, 1905225UH, 1903065WH, 1903085WH, 1903185WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905155WH, 1905175WH, and 1905225WH; 100254HS-V - 1903205WH, 1904015WH, 1904225WH, 1904265WH, 1904295WH, 1905025WH, 1905085WH, and 1905225PH; 100256HS-V - 1903065WH, 1903185WH, 1904015WH, and 1905155WH; 100304HS-V - 1903085NH, 1903135TH, 1904035TH, 1903065WH, 1905035PH, and 1905065WH; 100306HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1904085UH, 1903065WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225WH, 1904245WH, 1905035PH, 1905065WH, 1905205PH, and 1905225PH; 100308HS-V - 1903185UH, 1903225UH, 1905135UH, 1905175UH, 1905205UH, 1903085NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, and 1905065WH; 100406HS-V - 1903085WH, 1903185WH, 1904035WH, 1904225WH, and 1905205WH; 100408HS-V - 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1903115TH, 1903015WH, 1903065WH, 1904265WH, 1904295WH, 1905085WH, 1905135WH, 1905155WH, and 1905205PH; 100508HS-V - 1903225TH, 1905205NH, 1903015WH, 1903085WH, 1903135WH, 1903185WH, 1904265WH, 1905105WH, and 1905205WH
Amount recalled: 5,777 units

This recall covers 16 products

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

3 more are in the archive.

Where it was sold

Why it was recalled

The devices may be missing the implant coil.

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

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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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