Recall Z-1398-2020 ยท HCG Device, Neurovascular Embolization
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-V. Product Usage: The MCS is also intended for vascular occlus
| 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 | 3,442 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 |
| K090891 | MICROPLEX COIL SYSTEM-COSMOS MicroVention, Inc., Jun 22, 2009 |
| K093919 | MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V MicroVention, Inc., Jan 21, 2010 |
| 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 |