Detachable brain aneurysm coils recalled because they may fail to detach
Cerenovus is recalling 12,004 CEREPAK Detachable Coil System units because the coils may fail to detach, which could result in hemorrhagic and ischemic stroke. The FDA classified it Class I.
- Product
- CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM
- Category
- Medical Device
- Distribution
- Distributed nationwide