Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Reason for recall: Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted. Distribution: Nationwide US distribution. Worldwide international distribution. Quantity: 47 units (44 US, 3 OUS) Lot/code info: Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.
10607567108407
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.