Recall Z-1225-2020
Microvention, Inc. · initiated November 24, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
Reason for recall
The devices may be missing the implant coil.
FDA-determined 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).
Details
- Recall number
- Z-1225-2020
- Initiated
- November 24, 2019
- Terminated
- April 20, 2021
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Quantity
- 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.
- Recalling firm
- Microvention, Inc., Aliso Viejo, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1220-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization…The devices may be missing the implant coil. | 11/24/2019Terminated |
| Z-1221-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026…The devices may be missing the implant coil. | 11/24/2019Terminated |
| Z-1222-2020 Class II | Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032…The devices may be missing the implant coil. | 11/24/2019Terminated |
| Z-1223-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization…The devices may be missing the implant coil. | 11/24/2019Terminated |
| Z-1224-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026…The devices may be missing the implant coil. | 11/24/2019Terminated |