Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Reason for recall: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide Quantity: 7438 units Lot/code info: GTIN none, Serial Numbers: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046, HW11047, HW11050, HW11051, HW11052, HW11053, HW11054, HW11057, HW11060, HW11061, HW11062, HW11063, HW11064, HW11065, HW11067, HW11070, HW11071, HW11072, HW11074, HW11075, HW11076, HW11077, HW11078, HW11082, HW11083, HW11085, HW11086, HW11087, HW11088, HW11089, HW11091, HW11092, HW11093, HW11094, HW11096, HW11100, HW11101, HW11103, HW11105, HW11106, HW11107, HW11109, HW11111, HW11112, HW11113, HW11114, HW11116, HW11117, HW11118, HW11119, HW11120, HW11121, HW11122, HW11123, HW11125, HW11126, HW11129, HW11130, HW11133, HW11134, HW11137, HW11138, HW11139, HW11140, HW11141, HW11142, HW11146, HW11147, HW11148, HW11149, HW11150, HW11151, HW11152, HW11153, HW11155, HW11157, HW11160, HW11161, HW11164, HW11165, HW11166, HW11168, HW11171, HW11172, HW11173, HW11174, HW11176, HW11177, HW11178, HW11180, HW11181, HW11183, HW11184, HW11185, HW11186, HW11187, HW11188, HW11190, HW11191, HW11192, HW11193, HW11194, HW11195, HW11196, HW11197, HW11198, HW11199, HW11201, HW11202, HW11204, HW11205, HW11209, HW11210, HW11216, HW11217, HW11218, HW11219, HW11221, HW11222, HW11223, HW11224, HW11225, HW11227, HW11228, HW11229, HW11230, HW11231, HW11232, HW11233, HW11234, HW11235, HW11236, HW11239, HW11240, HW11241, HW11242, HW11244, HW11246, HW11247, HW11248, HW1125
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.