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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil

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 Class 2 Device Recall Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coilsee related information
Date Initiated by FirmNovember 24, 2019
Create DateFebruary 13, 2020
Recall Status1 Terminated 3 on April 20, 2021
Recall NumberZ-1225-2020
Recall Event ID 84585
510(K)NumberK151358 
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductTerumo 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
For Additional Information ContactDr. Irina Kulinets
714-247-8159
Manufacturer Reason
for Recall		The devices may be missing the implant coil.
FDA Determined
Cause 2		Other
ActionThe recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).
Quantity in Commerce1,187 units
DistributionThe 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KRD
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