Recall Z-1223-2020— Microvention, Inc.

Name: FDA recall Z-1223-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-24

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: K151358. Product: Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, 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 record

K151358 — AZUR CX Detachable 35 CoilsMicroVention, Inc.·cleared 2015-09-25

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

Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, 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.