Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Hazard

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

Details from the source

Reason for recall: Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. Distribution: US Nationwide. Global Distribution. Quantity: 9379 units Lot/code info: All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

UPC codes

10607567112312, 10607567108407, 10607567113449

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.