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: 10287 units Lot/code info: GTIN none, Serial Numbers: HW10001, HW10002, HW10003, HW10004, HW10005, HW10006, HW10007, HW10008, HW10009, HW10010, HW10011, HW10012, HW10013, HW10014, HW10015, HW10016, HW10017, HW10018, HW10019, HW10020, HW10021, HW10022, HW10023, HW10024, HW10025, HW10026, HW10027, HW10028, HW10029, HW10030, HW10031, HW10032, HW10033, HW10034, HW10035, HW10036, HW10037, HW10038, HW10039, HW10040, HW10041, HW10042, HW10043, HW10044, HW10045, HW10046, HW10047, HW10048, HW10049, HW10050, HW10051, HW10052, HW10053, HW10055, HW10056, HW10057, HW10058, HW10059, HW10060, HW10061, HW10062, HW10063, HW10064, HW10065, HW10066, HW10067, HW10068, HW10070, HW10071, HW10072, HW10073, HW10074, HW10075, HW10076, HW10077, HW10079, HW10080, HW10081, HW10082, HW10083, HW10084, HW10085, HW10086, HW10087, HW10088, HW10089, HW10090, HW10091, HW10092, HW10093, HW10094, HW10095, HW10096, HW10097, HW10098, HW10099, HW10100, HW10101, HW10102, HW10103, HW10104, HW10105, HW10106, HW10107, HW10108, HW10109, HW10110, HW10111, HW10112, HW10113, HW10114, HW10115, HW10116, HW10117, HW10118, HW10119, HW10120, HW10121, HW10122, HW10123, HW10124, HW10125, HW10126, HW10127, HW10128, HW10129, HW10130, HW10131, HW10132, HW10133, HW10135, HW10136, HW10137, HW10138, HW10139, HW10140, HW10141, HW10142, HW10143, HW10144, HW10145, HW10146, HW10147, HW10148, HW10149, HW10150, HW10151, HW10152, HW10153, HW10154, HW10155, HW10156, HW10157, HW10158, HW10159, HW10160, HW10161, HW10162, HW10163, HW10164, HW10165, HW10166, HW10167, HW1016
Official record: FDA (Device enforcement) ↗
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