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.
FDA Recall Z-1221-2020 · Posted None
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Recalling FirmMicrovention, Inc.
Recall StatusTerminated
Product CodeKRD
Date Initiated2019-11-24
Date Terminated2021-04-20
Product Quantity107 units
Reason for Recall
The devices may be missing the implant coil.
Firm Action
The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).
Root Cause
Other
Distribution Pattern
The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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