Z-1266-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- May 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429 batteries
Product Description
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Reason for Recall
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Distribution Pattern
Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.
Code Information
GTIN 00888707008778. Serial numbers BAT935012, BAT935059, BAT935008, BAT935009, BAT935018, BAT935020, BAT935022, BAT935023, BAT935047, BAT934999, BAT935003, BAT935010, BAT935329, BAT934928, BAT934934, BAT935160, BAT935078, BAT934997, BAT935027, BAT935048, BAT934953, BAT934933, BAT934948, BAT934853, BAT934854, BAT934858, BAT934895, BAT934899, BAT934901, BAT934903, BAT934904, BAT934905, BAT934927, BAT934932, BAT934935, BAT934940, BAT934979, BAT934981, BAT935109, BAT935112, BAT935116, BAT935117, BAT935120, BAT935122, BAT935124, BAT935127, BAT935132, BAT935133, BAT935134, BAT935136, BAT934846, BAT934848, BAT934849, BAT934850, BAT935137, BAT935142, BAT935143, BAT935145, BAT935146, BAT935148, BAT935150, BAT935151, BAT935152, BAT935154, BAT935155, BAT935156, BAT935157, BAT935158, BAT935161, BAT935162, BAT935163, BAT935164, BAT935260, BAT935301, BAT935302, BAT935303, BAT935201, BAT935202, BAT935203, BAT935172, BAT935173, BAT935174, BAT935175, BAT935176, BAT935177, BAT935178, BAT935179, BAT935180, BAT935181, BAT935182, BAT935183, BAT935184, BAT935185, BAT935186, BAT935187, BAT934910, BAT934912, BAT934914, BAT934915, BAT934916, BAT934919, BAT935317, BAT935318, BAT935319, BAT935320, BAT935322, BAT935324, BAT935217, BAT935264, BAT935269, BAT935276, BAT935277, BAT935282, BAT935283, BAT935285, BAT935286, BAT935287, BAT935312, BAT935313, BAT935314, BAT935188, BAT935189, BAT935190, BAT935191, BAT935192, BAT935193, BAT935194, BAT935195, BAT935196, BAT935197, BAT935198, BAT935199, BAT934851, BAT934852, BAT934855, BAT934857, BAT934859, BAT934861, BAT934862, BAT934863, BAT934865, BAT934866, BAT935207, BAT935210, BAT935222, BAT935256, BAT935257, BAT935230, BAT935231, BAT935233, BAT935234, BAT935236, BAT935237, BAT935238, BAT935268, BAT935270, BAT935271, BAT935272, BAT935273, BAT935275, BAT935279, BAT935280, BAT935288, BAT935290, BAT935291, BAT935292, BAT935284, BAT934844, BAT935229, BAT934917, BAT934918, BAT934920, BAT934924, BAT935232, BAT935235, BAT935247, BAT935261, BAT934867, BAT934868, BAT935265, BAT935266, BAT935204, BAT935205, BAT935206, BAT935212, BAT935213, BAT935216, BAT935250, BAT935251, BAT935252, BAT935253, BAT935254, BAT935267, BAT934869, BAT935200, BAT935262, BAT935218, BAT935219, BAT935227, BAT935228, BAT934871, BAT934873, BAT934874, BAT934875, BAT934876, BAT934877, BAT934878, BAT934880, BAT934881, BAT934882, BAT934883, BAT934884, BAT934886, BAT934909, BAT935138, BAT935140, BAT935293, BAT935294, BAT935296, BAT935259, BAT935297, BAT935298, BAT935299, BAT935300, BAT934894, BAT935326, BAT935331, BAT934982, BAT934987, BAT934988, BAT934989, BAT935032, BAT935038, BAT935039, BAT935040, BAT935042, BAT935043, BAT935051, BAT935068, BAT935074, BAT935085, BAT935089, BAT935093, BAT935094, BAT935095, BAT935098, BAT935099, BAT935100, BAT935101, BAT935102, BAT935103, BAT935104, BAT935105, BAT935106, BAT935107, BAT935108, BAT935141, BAT935144, BAT935147, BAT935149, BAT935159, BAT935165, BAT935166, BAT935167, BAT935168, BAT935169, BAT935170, BAT935171, BAT935258, BAT934887, BAT934889, BAT934891, BAT934893, BAT934870, BAT935239, BAT935240, BAT935241, BAT935242, BAT935243, BAT935244, BAT935245, BAT935246, BAT935248, BAT935249, BAT934906, BAT934908, BAT935033, BAT935036, BAT935044, BAT935017, BAT935045, BAT935001, BAT935026, BAT935114, BAT935118, BAT935121, BAT935123, BAT935263, BAT935274, BAT935278, BAT935281, BAT935315, BAT935084, BAT935086, BAT934896, BAT934897, BAT934898, BAT934949, BAT934950, BAT935323, BAT935325, BAT935327, BAT935328, BAT935330, BAT935332, BAT935005, BAT935006, BAT935025, BAT935062, BAT935064, BAT935065, BAT935208, BAT934922, BAT934926, BAT934929, BAT934930, BAT934942, BAT934943, BAT934944, BAT934945, BAT934955, BAT934959, BAT934961, BAT934964, BAT934967, BAT934968, BAT934969, BAT934970, BAT934976, BAT934977, BAT934978, BAT935002, BAT935014, BAT935049, BAT934973, BAT934974, BAT935087, BAT935091, BAT935097, BAT934962, BAT935041, BAT935046, BAT935050, BAT935053, BAT935057, BAT935058, BAT935061, BAT935063, BAT935067, BAT935071, BAT935077, BAT935080, BAT935081, BAT935088, BAT935090, BAT935092, BAT934952, BAT934954, BAT934958, BAT934921, BAT934923, BAT934925, BAT934931, BAT934941, BAT934951, BAT935015, BAT935016, BAT935019, BAT935021, BAT935096, BAT935111, BAT934998, BAT934956, BAT935024, BAT935028, BAT935034, BAT935037, BAT935069, BAT935070, BAT935215, BAT935321, BAT935135, BAT935029, BAT935030, BAT935031, BAT934946, BAT934983, BAT934984, BAT934986, BAT934992, BAT934971, BAT934972, BAT934975, BAT934980, BAT934995, BAT935000, BAT935007, BAT935013, BAT934947, BAT934996, BAT935011, BAT935052, BAT935054, BAT935056, BAT935082, BAT935072, BAT935073, BAT935075, BAT935076, BAT935004, BAT934990, BAT934991, BAT934993, BAT934994, BAT935079, BAT934985, BAT934963, BAT934965, and BAT934966. Expiration date 30-APR-22.