Reported Jun 29, 2022 · Ongoing
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Medtronic Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
- HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
- Lot codes and dates
- 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.
- Amount recalled
- 429 batteries
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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