Reported Mar 4, 2020 · Terminated

MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF…

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 HydroSoft 10
- HydroCoil Embolic System
- Endovascular Embolization Coil
- Helical
- Sterile
- Rx
- REF numbers 100101H2HS-V
- 100102H2HS-V
- 100103H2HS-V
- 100104H2HS-V
- 100151H2HS-V
- 100152H2HS-V
- 100153H2HS-V
- 100154H2HS-V
- 100201H2HS-V
- 100202H2HS-V
- 100203H2HS-V
- 100204H2HS-V
- 100206H2HS-V
- 100208H2HS-V
- 100254H2HS-V
- 100256H2HS-V
- 100304H2HS-V
- 100306H2HS-V
- 100308H2HS-V
- 100310H2HS-V
- 100404H2HS-V
- 100406H2HS-V
- 100408H2HS-V
- 100410H2HS-V
- 100506H2HS-V
- 100508H2HS-V
- 100510H2HS-V
- 100515H2HS-V
- 100520H2HS-V
- 100620H2HS-V
and MV-00208HHSA - 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. The firm name on the label is MicroVention, Inc., Tustin, CA

Lot codes and dates: Catalog/lot numbers
299 of 299 codes
100101H2HS-V - 1903135UR
1903185UR
1903225UR
and 1904035UR
100102H2HS - V -1903135UR
1903155UR
1903155ZR
1903185UR
1903205UR
1904035UR
1904055UR
1904085UR
1904105UR
1904155UR
1904175UR
1904175ZR
and 1904245UR
100103H2HS-V - 1903015UR
1903045UR
1903065UR
1903085UR
1903135UR
1903205UR 1904055UR
1904085UR
1904155UR
1905085UR
1905105UR
1905135UR
and 1905155UR
100104H2HS-V - 1903015UR
1903135UR
1903205UR
1904085UR
1904105UR
and 1904155UR
100151H2HS-V - 1903085UR
1903185UR
and 1904015UR
100152H2HS-V - 1903135UR
1903155UR
1903205NR
1903205UR
1904035UR
1904055UR
1904085UR
1904105UR
1904155UR
1904175UR
1904225UR
1904245UR
1904265UR
1904295UR
1905025UR
1905035UR
1905065UR
1905085UR
1903045WR
1903185WR
1903205WR
1904105WR
Amount recalled: 2,762 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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