--- title: "Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... — FDA record Z-1110-2022 | Is It on Recall" description: "Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ven" url: https://isitonrecall.com/recall/fda-device-z-1110-2022-instructions-for-use-patient-manuals-and-emergency-responder-guides-for-heartware-ventricular-assist/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) ... — FDA record Z-1110-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Mar 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001 - **Reason**: Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system. - **Classification**: Class II - **Recalling firm**: Medtronic Inc - **Quantity**: 21,118 pieces of product literature - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1110-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1110-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29727, HW29741, HW29754, HW29755, HW29764, HW29776, HW29780, HW29781, HW29782, HW29784, HW29786, HW29787, HW29788, HW29790, HW29791, HW29798, HW29815, HW29820, HW29825, HW29832, HW29836, HW29850, HW29866, HW29867, HW29873, HW29877, HW29887, HW29894, HW29895, HW29896, HW29900, HW29903, HW29904, HW29909, HW29911, HW29915, HW29922, HW29923, HW29927, HW29928, HW29932, HW29949, HW29965, HW29976, HW29983, HW29990, HW29995, HW30038, HW30039, HW30040, HW30079, HW30080, HW30081, HW30082, HW30083, HW30084, HW30085, HW30086, HW30087, HW30088, HW30089, HW30102, HW30103, HW30104, HW30105, HW30106, HW30107, HW30108, HW30109, HW30110, HW30111, HW30112, HW30113, HW30115, HW30116, HW30117, HW30118, HW30147, HW30148, HW30149, HW30150, HW30151, HW30152, HW30153, HW30154, HW30155, HW30156, HW30157, HW30178, HW30193, HW30194, HW30195, HW30196, HW30197, HW30198, HW30199, HW30200, HW30201, HW30202, HW30204, HW30205, HW30207, HW30208, HW30209, HW30210, HW30211, HW30212, HW30213, HW30214, HW30224, HW30225, HW30226, HW30227, HW30231, HW30267, HW30319, HW30320, HW30342, HW30358, HW30360, HW30363, HW30364, HW30365, HW30366, HW30367, HW30369, HW30370, HW30372, HW30376, HW30378, HW30380, HW30382, HW30383, HW30384, HW30385, HW30387, HW30390, HW30392, HW30393, HW30397, HW30398, HW30399, HW30400, HW30402, HW30404, HW30406, HW30407, HW30408, HW30409, HW30410, HW30430, HW30449, HW30455, HW30461, HW30462, HW30463, HW30471, HW30472, HW30473, HW30475, HW30483, HW30484, HW30485, HW30486, HW30491, HW30494, HW30498, HW30595, HW30596, HW30597, HW30598, HW30599, HW30600, HW30601, HW30602, HW30603, HW30604, HW30606, HW30607, HW30608, HW30651, HW30652, HW30654, HW30656, HW30768, HW30769, HW30770, HW30771, HW30808, HW30809, HW30810, HW30811, HW30813, HW30814, HW30815, HW30816, HW30818, HW30820, HW30821, HW30822, HW30823, HW30824, HW30825, HW30829, HW30830, HW30863, HW30864, HW30865, HW30866, HW30867, HW30868, HW30869, HW30870, HW30871, HW30953, HW30954, HW30955, HW30956, HW30957, HW30958, HW30959, HW30960, HW30961, HW30962, HW30963, HW30964, HW30966, HW30967, HW30968, HW30970, HW30971, HW30972, HW30973, HW30974, HW30976, HW31015, HW31020, HW31072, HW31076, HW31087, HW31101, HW31103, HW31104, HW31105, HW31107, HW31111, HW31113, HW31114, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31226, HW31228, HW31232, HW31235, HW31242, HW31244, HW31249, HW31251, HW31254, HW31255, HW31258, HW31260, HW31261, HW31262, HW31267, HW31383, HW31386, HW31387, HW31388, HW31390, HW31398, HW31399, HW31402, HW31409, HW31410, HW31411, HW31412, HW31414, HW31445, HW31446, HW31447, HW31448, HW31449, HW31451, HW31452, HW31453, HW31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731, HW29208R01, HW29209R01, HW29225R01, HW29226R01, HW29241R01, HW29242R01, HW29245R01, HW29247R01; GTIN 00888707003063, Serial Numbers: HW41903, HW41911, HW41924, HW41925, HW41926, HW41927, HW41928, HW41929, HW41950, HW41953, HW42004, HW42006, HW42007, HW42008, HW42018, HW42019, HW42089, HW42158, HW42160, HW42161, HW42219, HW42230, HW42235, HW42237, HW42238, HW42650, HW42651, HW42678, HW42720, HW42724, HW42790, HW42793, HW42797, HW42829, HW42831, HW43009; GTIN 00888707003070, Serial Numbers: HW41892, HW41894, HW41895, HW41897, HW41899, HW41900, HW41901, HW41932, HW41934, HW41936, HW41937, HW41938, HW41939, HW41940, HW41941, HW41971, HW41972, HW41973, HW41974, HW41975, HW41977, HW41986, HW41991, HW41993, HW41994, HW41997, HW42000, HW42001, HW42002, HW42005, HW42009, HW42021, HW42022, HW42026, HW42099, HW42101, HW42103, HW42104, HW42110, HW42111, HW42114, HW42116, HW42148, HW42153, HW42155, HW42157, HW42223, HW42225, HW42228, HW42229, HW42232, HW42233, HW42252, HW42291, HW42307, HW42326, HW42328, HW42329, HW42330, HW42331, HW42332, HW42333, HW42500, HW42666, HW42915; GTIN 00888707003100, Serial Numbers: HW41961, HW41962, HW41964, HW41965, HW41966, HW41967, HW41968, HW42313, HW42660, HW42663, HW42671, HW42672, HW42901; GTIN 00888707003117, Serial Numbers: HW41955, HW41957, HW41958, HW41959, HW41960, HW42023, HW42024, HW42025, HW42061, HW42091, HW42130, HW42292, HW42335, HW42337, HW42339, HW42647, HW42665; GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990; GTIN 00888707003254, Serial Numbers: HW41943, HW41944, HW42213; GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997; GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35562, HW35571, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36006, HW36007, HW36008, HW36009, HW36010, HW36013, HW36018, HW36019, HW36020, HW36021, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36633, HW36636, HW36637, HW36654, HW36655, HW36659, HW36660, HW36662, HW36664, HW36669, HW36670, HW36671, HW36672, HW36673, HW36677, HW36678, HW36680, HW36681, HW36683, HW36685, HW36702, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36718, HW36719, HW36720, HW36722, HW36723, HW36724, HW36725, HW36726, HW36727, HW36728, HW36750, HW36752, HW36753, HW36754, HW36755, HW36785, HW36786, HW36788, HW36789, HW36812, HW36813, HW36815, HW36816, HW36817, HW36818, HW36823, HW36827, HW36829, HW36830, HW36831, HW36832, HW36833, HW36834, HW36835, HW36836, HW36837, HW36839, HW36840, HW36853, HW36854, HW36855, HW36877, HW36881, HW36882, HW36883, HW36891, HW36897, HW36898, HW36899, HW36900, HW36901, HW36902, HW36919, HW... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1110-2022%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: May 25, 2022 - **Recall initiation date**: Mar 30, 2022 - **Center classification date**: May 17, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1110-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc records](https://isitonrecall.com/brand/medtronic-inc/)