"Conductor fracture has been caused in 3 cases by accidental trauma (such as cutting implement). In all the other 8 cases, it has now been confirmed that the patient did not wear a lead support belt in accordance with instructions for use".
"The field safety notice on the VZ166 has not affected the company's other product such as the LVA3 VentrAssist LVAD......and remains available for sale in Australia and overseas..."
IMO, device efficacy is not affect. Also, as summised (refer to earlier post), one product is available for implanting, meaning revenue continues.
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