Potential Pump Malfunction Results In Class I Recall For LifeSPARC Circulatory System
The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.
You may also be interested in...
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
London-based cardiac surgery and neuroscience group LivaNova PLC is buying privately held Pittsburgh-based TandemLife in a deal worth up to $250m. TandemLife develops advanced cardiopulmonary temporary support systems that are complementary to LivaNova's cardiac surgery segments.
FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts Elsewhere
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.