Safety Notice for the EkoSonic MACH4 Endovascular Device, EKOS Corporation
2012.09.14
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05505/12
EKOS Corporation has issued a Field Safety Notice concerning new warnings in EkoSonic Endovascular Device Instruction for Use. For the introduction, EkoSonic MACH4 must not be used with an introducer sheath with a rotating hemostasis valve.