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Recall Observatory FDA recall evidence

Device 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.

Z-1221-2020

November 24, 2019

Class II

Product summary

Firm
Microvention, Inc.
Event
Event 84585
Status
Terminated
Classification
Class II
Quantity
107 units
Official record key
device-enforcement:Z-1221-2020

Official wording

Reason: The devices may be missing the implant coil.

Code information: Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904155J5; 45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and 45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The devices may be missing the implant coil.