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Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.
Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.