Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Hazard

An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.

Details from the source

Reason for recall: An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit. Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA Quantity: 4062 Total Lot/code info: All serial numbers. Model Number 0998-00-0800-75, UDI-DI 10607567112312; Model Number 0998-00-0800-83, UDI-DI 10607567108407; Model Number 0998-00-0800-85, UDI-DI 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.