Recall Z-1221-2020— Microvention, Inc.
Class II · Terminated
Class II FDA medical device recall by Microvention, Inc., initiated 2019-11-24, terminated 2021-04-20. It names one FDA 510(k) clearance: K120630. Product: Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.. Reason: The devices may be missing the implant coil..
- Recalling firm
- Microvention, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-24
- Terminated
- 2021-04-20
- Firm location
- Aliso Viejo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Reason for recall
The devices may be missing the implant coil.
Data sourced from openFDA. This site is unofficial and independent of the FDA.