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 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog/lot numbers: 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; 100415HFRM-V - 1904105WF, 1904225PF, and 1905035WF; 100510HFRM-V - 1903015WF, 1903185WF, 1904175WF, 1905155WF, and 1905205RF; 100515HFRM-V - 1903015WF, 1903085WF, 1903185WF, 1904105WF, 1904175WF, 1904225PF, 1904225WF, 1904245WF, 1905085WF, 1903085UF, 1903135UF, 1903155UF, 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904175UF, 1904175ZF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905225UF; 100519HFRM-V - 1905155UF; 100612HFRM-V - 1903185WF, 1903225WF, and 1905205WF; 100619HFRM-V - 1903065WF, 1903185WF, 1903225WF, 1905155WF, 1903085UF, 1903155UF, 1903225UF, 1904155UF, 1904175UF, 1904225UF, and 1904245UF; 100623HFRM-V - 1903115UF; 100715HFRM-V - 1903045WF, 1903115WF, 1903135WF, 1903185WF, and 1903155QF; 100728HFRM-V - 1903015WF, 1903085WF, 1905155WF, and 1904225UF; 100817HFRM-V - 1903045WF, 1903135WF, and 1905155WF; 100833HFRM-V - 1903015WF, 1903045WF, 1903085WF, 1905155WF, 1905205WF, 1904055UF, and 1904225UF; 100931HFRM-V - 1903085WF, 1903185WF, 1904225PF, 1905155WF, 1903205UF, 1904015UF, 1904035UF, 1904265UF, and 1904295UF; 101036HFRM-V - 1903015WF, 1904225PF, 1905155WF, and 1904175UF; MV-00408HHFA - 1905175YF; MV-00510HHFA - 1905105YF; MV-00515HHFA - 1905175YF and 1905205YF; and MV-00619HHFA - 1905035YF and 1905175YF.
- 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 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 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.
Product Codes/Lot Numbers:
Catalog/lot numbers: 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; 100415HFRM-V - 1904105WF, 1904225PF, and 1905035WF; 100510HFRM-V - 1903015WF, 1903185WF, 1904175WF, 1905155WF, and 1905205RF; 100515HFRM-V - 1903015WF, 1903085WF, 1903185WF, 1904105WF, 1904175WF, 1904225PF, 1904225WF, 1904245WF, 1905085WF, 1903085UF, 1903135UF, 1903155UF, 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904175UF, 1904175ZF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905225UF; 100519HFRM-V - 1905155UF; 100612HFRM-V - 1903185WF, 1903225WF, and 1905205WF; 100619HFRM-V - 1903065WF, 1903185WF, 1903225WF, 1905155WF, 1903085UF, 1903155UF, 1903225UF, 1904155UF, 1904175UF, 1904225UF, and 1904245UF; 100623HFRM-V - 1903115UF; 100715HFRM-V - 1903045WF, 1903115WF, 1903135WF, 1903185WF, and 1903155QF; 100728HFRM-V - 1903015WF, 1903085WF, 1905155WF, and 1904225UF; 100817HFRM-V - 1903045WF, 1903135WF, and 1905155WF; 100833HFRM-V - 1903015WF, 1903045WF, 1903085WF, 1905155WF, 1905205WF, 1904055UF, and 1904225UF; 100931HFRM-V - 1903085WF, 1903185WF, 1904225PF, 1905155WF, 1903205UF, 1904015UF, 1904035UF, 1904265UF, and 1904295UF; 101036HFRM-V - 1903015WF, 1904225PF, 1905155WF, and 1904175UF; MV-00408HHFA - 1905175YF; MV-00510HHFA - 1905105YF; MV-00515HHFA - 1905175YF and 1905205YF; and MV-00619HHFA - 1905035YF and 1905175YF.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1402-2020
Related Recalls
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
MICROVENTION
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.