Recall Z-1396-2020— Microvention, Inc.
Class II · Terminated
Class II FDA medical device recall by Microvention, Inc., initiated 2019-11-22, terminated 2022-01-26. It names 4 FDA 510(k) clearances: K153594, K132952, K131948 and 1 more. Product: 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 in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.. Reason: The devices may be missing the implant coil..
- Recalling firm
- Microvention, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-22
- Terminated
- 2022-01-26
- Firm location
- Aliso Viejo, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K153594 — MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
- K132952 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K131948 — MICROPLEX COIL SYSTEM (MCS)
- K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.
Reason for recall
The devices may be missing the implant coil.
Data sourced from openFDA. This site is unofficial and independent of the FDA.