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.
This recall has been terminated (originally issued November 24, 2019).
- Company
- Microvention Inc.
- Recall Initiated
- November 24, 2019
- Terminated
- April 20, 2021
- Recall Number
- Z-1225-2020
- Quantity
- 1,187 units
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The devices may be missing the implant coil.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).