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.
- Company
- Microvention Inc.
- Recall Initiated
- November 22, 2019
- Terminated
- January 26, 2022
- Recall Number
- Z-1402-2020
- Quantity
- 991 units
- Firm Location
- Aliso Viejo, CA
Reason for Recall
The devices may be missing the implant coil.
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 Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Lot / Code Info
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.
Root 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).