Recall Z-1403-2020 ยท HCG Device, Neurovascular Embolization
Microvention, Inc.
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
| 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 | 32 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 |
| 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 |