Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Check against the official notice below — it lists the full affected range.
Datascope Corp. is correcting certain Cardiosave Rescue IntraAortic Balloon Pump devices due to a risk of fluid entering the device. If fluid ingresses, it may damage electronic components and cause the system to shut down, potentially resulting in unsafe hemodynamic instability. The affected models are 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, and 0998-UC-0800-85, with all serial numbers potentially involved. A total of 44 units were distributed in the US and 5 units were distributed outside the US.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Reason for recall: Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. Distribution: Worldwide distribution - US Nationwide. Quantity: 44 (US); 5 (OUS) Lot/code info: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.