Device Recall TriActiv FX Embolic Protection System 7F

Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.

General and Plastic Surgery Devices

Unclassified

No

Worldwide, including USA and Germany.

TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.