Recall Z-1396-2020 ยท HCG Device, Neurovascular Embolization
Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS 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
| 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 | 9 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 |
| K131948 | MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc., Oct 4, 2013 |
| 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 |