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Class 2 Device Recall Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil |
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Date Initiated by Firm |
November 24, 2019 |
Create Date |
February 13, 2020 |
Recall Status1 |
Terminated 3 on April 20, 2021 |
Recall Number |
Z-1225-2020 |
Recall Event ID |
84585 |
510(K)Number |
K151358
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Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
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Product |
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica. |
Code Information |
Catalog/lot numbers: 45-751019 - 1903045J2, 1903065J2, 1903085J2, 1904155J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905085J2, 1905105K2, and 1905135J2; 45-751324 - 1903045J2, 1903155J2, 1903205J2, 1903225J2, 1904155J2, 1904225J2, 1904265J2, 1904295J2, 1905065J2, and 1905085J2; 45-751632 - 1903045J2, 1903065J2, 1903205J2, 1903225J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905065J2, and 1905085J2; 45-752039 - 1903045J2, 1903205J2, 1904265J2, 1905035J2, and 1905065J2; 45-750407 - 1903045J2, 1903065J2, 1903085J2, 1903115J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, and1904295J2 45-750511 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, 1904295J2; 45-750617 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904055J2, 1905035J2, 1905065J2, and 1905085J2; 45-750609 - 1903045J2, 1903065J2, 1903085J2, and 1904035J2; 45-750812 - 1903045J2, 1903085J2, 1905035J2, 1905065J2, and 1905085J2; 45-750824 - 1903045J2, 1903065J2, 1903155J2 ,1904055J2, 1905035J2, 1905065J2, and 1905085J2; MV-AX50407CD - 1904015J9, 1904035J9, and 1904085J9; MV-AX50511CD - 1904015J9, 1904035J9, and 1904055J9; MV-AX50617CD - 1904015J9 and 1904035J9; MV-AX50824CD - 1904015J9 and 1904035J9; and MV-AX51019CD - 1905105J9. |
Recalling Firm/ Manufacturer |
Microvention, Inc. 35 Enterprise Aliso Viejo CA 92656-2601
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For Additional Information Contact |
Dr. Irina Kulinets 714-247-8159
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Manufacturer Reason for Recall |
The devices may be missing the implant coil.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians). |
Quantity in Commerce |
1,187 units |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KRD and Original Applicant = Micro Vention, Inc.
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