Reported Mar 4, 2020 · Terminated

MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers…

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 HydroFrame 10
- HydroCoil Embolic System
- Endovascular Embolization Coil
- Sterile
- Rx
- REF numbers 100306HFRM-V
- 100405HFRM-V
- 100408HFRM-V
- 100410HFRM-V
- 100412HFRM-V
- 100415HFRM-V
- 100510HFRM-V
- 100515HFRM-V
- 100519HFRM-V
- 100612HFRM-V
- 100619HFRM-V
- 100623HFRM-V
- 100715HFRM-V
- 100728HFRM-V
- 100817HFRM-V
- 100833HFRM-V
- 100931HFRM-V
- 101036HFRM-V
- MV-00408HHFA
- MV-00510HHFA
- MV-00515HHFA
- and MV-00619HHFA
Product UsageThe HES 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

Lot codes and dates: Catalog/lot numbers
148 of 148 codes
100306HFRM-V - 1903135WF
1903155WF
1903015UF
1903065UF
1903065ZF
1903085UF
1903135UF
1903155NF
1903205UF
1904015UF
1904035UF
1904155UF
1904175UF
1904225UF
1904245UF
1904265UF
1905085UF
1905105UF
1905135UF
1905155UF
and 1905175UF
100405HFRM-V - 1903015WF
1903085WF
1904225PF
and 1905155WF
100408HFRM-V - 1903015WF
1903065WF
1903085WF
1903155WF
1903225WF
1904225PF
1905155WF
1903015UF
1903135UF
1903205UF
1903225UF
1904175UF
1904225UF
1904245UF
1904265UF
1904295UF
1905025UF
1905085UF
1905135UF
and 1905155UF
100410HFRM-V - 1903085WF and 1904055WF
100412HFRM-V - 1903205UF
1903225UF
1904015UF
1904035UF
1904055UF
1904155UF
1904175UF
1904225UF
1904245UF
1904265UF
1904295UF
1905155UF
1905205UF
and 1905225UF
Amount recalled: 991 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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