Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 099
Check against the official notice below — it lists the full affected range.
Datascope Corp. is correcting its Cardiosave Hybrid IntraAortic Balloon Pump due to the possibility of fluid entering the device. If fluid ingress occurs, it may short electronic components and cause the system to shut down, potentially resulting in unsafe hemodynamic instability. The recall affects 5,566 units distributed in the United States and 6,354 units distributed outside the United States across multiple model numbers (0998-00-0800-31 through 0998-UC-0800-65) and all serial numbers.
The recall record does not specify a remedy or instructions 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: 5,566 (US); 6,354 (OUS) Lot/code info: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-65, 10607567113432
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.