Recall Z-1402-2020 ยท HCG Device, Neurovascular Embolization
Microvention, Inc.
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
| Date | Nov 22, 2019 |
| Status | Terminated |
| Reason | The devices may be missing the implant coil. |
| Root cause | Process design |
| Action | 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). |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050954 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc., Jun 28, 2005 |
| K090357 | HYDROFRAME (HES) MicroVention, Inc., Apr 10, 2009 |
| K103758 | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 MicroVention, Inc., Apr 28, 2011 |
| K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc., Dec 19, 2013 |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MicroVention, Inc., Jan 22, 2016 |
| K161367 | HydroCoil Embolic System (HES) MicroVention, Inc., Aug 31, 2016 |