Every recall we track for LivaNova USA — 5 in all — plus the complaints and injury reports the public filed about them.
LivaNova recalls specific Perfusion Packs (Rx only, sterile) due to potential leaks or blockages in surgical tubing systems used for up to six hours of extracorporeal support.
LivaNova recalls Sorin Stockert Heater-Cooler System 3T units with specific item and serial numbers due to suspected microbial contamination and visible biofilm. Affected units may require cleaning or replacement.
LivaNova recalls Inspire 6 Integrated Phisio OXY with HVR Reservoir due to incorrect expiration date in UDI barcode. The expiration date is printed as DDMMYY instead of YYMMDD, but package labels show correct dates.
LivaNova recalls Inspire 8 Integrated Phisio OXY with HVR Reservoir due to incorrect expiration date printed in the UDI barcode. The expiration date is listed as DDMMYY instead of YYMMDD, though package labels show correct dates.
LivaNova recalls Smart Perfusion Pack E-Packs with incorrect expiration dates on labels. This may lead to improper use if the product expires before intended use. Affected units include specific model numbers and lots.
