Recall Z-1402-2020
Microvention, Inc. · initiated November 22, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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…
Reason for recall
The devices may be missing the implant coil.
FDA-determined cause: Process design
Action taken
The recalling firm issued letters beginning 11/22/2019 dated 11/26/2019 via email using different flags according to the region the foreign consignee was located, i.e. 'URGENT: FIELD SAFETY CORRECTION ACTION" (for EMEA), "URGENT: MEDICAL DEVICE RECALL" (for Japan), or "FIELD SAFETY ADVISORY NOTICE" (for Rest of World).
Details
- Recall number
- Z-1402-2020
- Initiated
- November 22, 2019
- Terminated
- January 26, 2022
- Product code
- HCG – Device, Neurovascular Embolization
- Quantity
- 991 units
- Distribution
- All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak…
- Recalling firm
- Microvention, Inc., Aliso Viejo, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1392-2020 Class II | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1393-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1394-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1395-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1396-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1397-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1398-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1399-2020 Class II | MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1400-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1401-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1403-2020 Class II | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1404-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1405-2020 Class II | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1406-2020 Class II | MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |
| Z-1407-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | 11/22/2019Terminated |