MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Microvention, Inc.
- Reason for Recall:
- The devices may be missing the implant coil.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The 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.
Product Codes/Lot Numbers:
Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1403-2020
Related Recalls
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MICROVENTION
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