FDA Enforcement Class I Ongoing

HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.

Recall: Z-1266-2022 · Reported June 29, 2022

Enforcement

Recall Number: Z-1266-2022
Event ID: 90228
Classification: Class I
Status: Ongoing
Product Type: Devices
Firm: Medtronic Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: June 29, 2022
Initiation Date: May 5, 2022
Classification Date: June 21, 2022
Address: 710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, 55432-5603, United States

Description

Reason

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.

Code Info

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.

Distribution

Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.

Quantity

429 batteries