Reported Dec 19, 2018 · Terminated
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare…
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- Medtronic HeartWare Ventricular Assist HVAD System Battery
- Charger Model 1600US - Product UsageThe HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires
- two power sources for safe operationeither two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger
- Lot codes and dates
- BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471, BCH000472, BCH000475, BCH000484, BCH000485, BCH000486, BCH000490, BCH000493, BCH000495, BCH000500, BCH000502, BCH000503, BCH000507, BCH000514, BCH000523, BCH000524, BCH000525, BCH000526, BCH000527, BCH000528, BCH000530, BCH000531, BCH000534, BCH000537, BCH000543, BCH000553, BCH000554, BCH000556, BCH000564, BCH000565, BCH000567, BCH000570, BCH000573, BCH000574, BCH000575, BCH000576, BCH000577, BCH000579, BCH000580, BCH000583, BCH000586, BCH000590, BCH000592, BCH000593, BCH000594, BCH000595, BCH000598, BCH000601, BCH000602, BCH000603, BCH000607, BCH000610, BCH000612, BCH000616, BCH000628, BCH000631, BCH000633, BCH000635, BCH000637, BCH000640, BCH000644, BCH000645, BCH000653, BCH000654, BCH000656, BCH000657, BCH000658, BCH000659, BCH000660, BCH000666, BCH000667, BCH000668, BCH000670, BCH000671, BCH000675, BCH000676, BCH000677, BCH000680, BCH000688, BCH000690, BCH000691, BCH000693, BCH000694, BCH000695, BCH000696, BCH000697, BCH000698, BCH000702, BCH000703, BCH000706, BCH000713, BCH000715, BCH000716, BCH000721, BCH000722, BCH000728, BCH000733, BCH000734, BCH000735, BCH000739, BCH000740, BCH000743, BCH000745, BCH000748, BCH000750, BCH000757, BCH000758, BCH000760, BCH000761, BCH000762, BCH000763, BCH000764, BCH000767, BCH000769, BCH000771, BCH000772, BCH000776, BCH000783, BCH000869, BCH000870, BCH000872, BCH000873, BCH000876, BCH000877, BCH000881, BCH000885, BCH000887, BCH000888, BCH000890, BCH000894, BCH000895, BCH000902, BCH000906, BCH000914, BCH000915, BCH000921, BCH000924, BCH000925, BCH000926, BCH000930, BCH000931, BCH000938, BCH000941, BCH000945, BCH000946, BCH000947, BCH000948, BCH000949, BCH000950, BCH000953, BCH000954, BCH000959, BCH000964, BCH000966, BCH000967, BCH000976, BCH000977, BCH000979, BCH000985, BCH000987, BCH000989, BCH000991, BCH000993, BCH000994, BCH000995, BCH001004, BCH001005, BCH001007, BCH001009, BCH001010, BCH001011, BCH001015, BCH001016, BCH001025, BCH001035, BCH001036, BCH001040, BCH001042, BCH001043, BCH001044, BCH001045, BCH001047, BCH001049, BCH001056, BCH001063, BCH001065, BCH001072, BCH001086, BCH001091, BCH001103, BCH001109, BCH001110, BCH001111, BCH001112, BCH001114, BCH001117, BCH001118, BCH001119, BCH001121, BCH001129, BCH001134, BCH001136, BCH001142, BCH001152, BCH096768, BCH096770, BCH096771, BCH096773, BCH096775, BCH096779, BCH096782, BCH096785, BCH096787, BCH096789, BCH096790, BCH096791, BCH096794, BCH096796, BCH096799, BCH096800, BCH096801, BCH096804, BCH096805, BCH096806, BCH096811, BCH096812, BCH096813, BCH096818, BCH096820, BCH096821, BCH096822, BCH096827, BCH096828, BCH096830, BCH096832, BCH096833, BCH096836, BCH096850, BCH096924, BCH096936, BCH096947, BCH096954, BCH096956, BCH096959, BCH096962, BCH096963, BCH096964, BCH096967, BCH096968, BCH096969, BCH096972, BCH096973, BCH096974, BCH096975, BCH096976, BCH096977, BCH096978, BCH096979, BCH096981, BCH096983, BCH096984, BCH096985, BCH096986, BCH096987, BCH096989, BCH096990, BCH096992, BCH096993, BCH096994, BCH096996, BCH096997, BCH096998, BCH096999, BCH097001, BCH097003, BCH097004, BCH097005, BCH097006, BCH097007, BCH097010, BCH097012, BCH097013, BCH097014, BCH097015, BCH097016, BCH097017, BCH097020, BCH097021, BCH097022, BCH097051, BCH097052, BCH097053, BCH097054, BCH097055, BCH097056, BCH097060, BCH097061, BCH097066, BCH097067, BCH097068, BCH097069, BCH097070, BCH097075, BCH097076, BCH097078, BCH097079, BCH097083, BCH097088, BCH097091, BCH097092, BCH097094, BCH097096, BCH097098, BCH097100, BCH097101, BCH097103, BCH097104, BCH097107, BCH097110, BCH097112, BCH097113, BCH097114, BCH097117, BCH097120, BCH097122, BCH097123, BCH097125, BCH097129, BCH097131, BCH097132, BCH097134, BCH097135, BCH097137, BCH097199, BCH097201, BCH097202, BCH097206, BCH097208, BCH097209, BCH097210, BCH097211, BCH097212, BCH097213, BCH097214, BCH097215, BCH097217, BCH097218, BCH097219, BCH097222, BCH097224, BCH097225, BCH097226, BCH097227, BCH097228, BCH097230, BCH097232, BCH097233, BCH097235, BCH097236, BCH097237, BCH097238, BCH097240, BCH097241, BCH097243, BCH097244, BCH097245, BCH097246, BCH097249, BCH097250, BCH097254, BCH097255, BCH097257, BCH097259, BCH097260, BCH097263, BCH097264, BCH097265, BCH097269, BCH097272, BCH097273, BCH097275, BCH097279, BCH097312, BCH097328, BCH097359, BCH097363, BCH097370, BCH097374, BCH097375, BCH097382, BCH097383, BCH097385, BCH097387, BCH097388, BCH097392, BCH097395, BCH097397, BCH097398, BCH097400, BCH097404, BCH097405, BCH097406, BCH097407, BCH097408, BCH097409, BCH097411, BCH097418, BCH097419, BCH097420, BCH097425, BCH097426, BCH097428, BCH097429, BCH097430, BCH097431, bch097432, BCH097433, BCH097434, BCH097437, BCH097438, BCH097439, bch097440, BCH097441, BCH097443, bch097446, bch097447, bch097448, bch097449, bch097450, bch097451, bch097452, bch097453, BCH097454, bch097458, BCH097460, BCH097461, BCH097462, BCH097464, BCH097466, bch097467, bch097468, bch097470, BCH097472, BCH097473, BCH097474, BCH097475, BCH097477, BCH097478, BCH097480, BCH097482, BCH097484, BCH097485, BCH097488, BCH097489, BCH097490, BCH097491, BCH097492, BCH097495, BCH097496, BCH097497,
2,146 of 2,146 codes
bch097498BCH097499BCH097506BCH097507bch097509BCH097511BCH097516BCH097519BCH097520bch097524BCH097525BCH097526BCH097528BCH097529BCH097530BCH097534BCH097538BCH097545BCH097548BCH097560BCH097568BCH097569BCH097578BCH097582BCH097586BCH097587BCH097588BCH097591BCH097593BCH097595BCH097596BCH097607BCH097610BCH097611BCH097617BCH097621BCH097623BCH097624BCH097625BCH097627BCH097628BCH097629BCH097630BCH097631BCH097633BCH097634BCH097635BCH097636BCH097638BCH097639BCH097640BCH097643BCH097644BCH097645BCH097646BCH097647BCH097649BCH097650BCH097651BCH097652
- BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471, BCH000472, BCH000475, BCH000484, BCH000485, BCH000486, BCH000490, BCH000493, BCH000495, BCH000500, BCH000502, BCH000503, BCH000507, BCH000514, BCH000523, BCH000524, BCH000525, BCH000526, BCH000527, BCH000528, BCH000530, BCH000531, BCH000534, BCH000537, BCH000543, BCH000553, BCH000554, BCH000556, BCH000564, BCH000565, BCH000567, BCH000570, BCH000573, BCH000574, BCH000575, BCH000576, BCH000577, BCH000579, BCH000580, BCH000583, BCH000586, BCH000590, BCH000592, BCH000593, BCH000594, BCH000595, BCH000598, BCH000601, BCH000602, BCH000603, BCH000607, BCH000610, BCH000612, BCH000616, BCH000628, BCH000631, BCH000633, BCH000635, BCH000637, BCH000640, BCH000644, BCH000645, BCH000653, BCH000654, BCH000656, BCH000657, BCH000658, BCH000659, BCH000660, BCH000666, BCH000667, BCH000668, BCH000670, BCH000671, BCH000675, BCH000676, BCH000677, BCH000680, BCH000688, BCH000690, BCH000691, BCH000693, BCH000694, BCH000695, BCH000696, BCH000697, BCH000698, BCH000702, BCH000703, BCH000706, BCH000713, BCH000715, BCH000716, BCH000721, BCH000722, BCH000728, BCH000733, BCH000734, BCH000735, BCH000739, BCH000740, BCH000743, BCH000745, BCH000748, BCH000750, BCH000757, BCH000758, BCH000760, BCH000761, BCH000762, BCH000763, BCH000764, BCH000767, BCH000769, BCH000771, BCH000772, BCH000776, BCH000783, BCH000869, BCH000870, BCH000872, BCH000873, BCH000876, BCH000877, BCH000881, BCH000885, BCH000887, BCH000888, BCH000890, BCH000894, BCH000895, BCH000902, BCH000906, BCH000914, BCH000915, BCH000921, BCH000924, BCH000925, BCH000926, BCH000930, BCH000931, BCH000938, BCH000941, BCH000945, BCH000946, BCH000947, BCH000948, BCH000949, BCH000950, BCH000953, BCH000954, BCH000959, BCH000964, BCH000966, BCH000967, BCH000976, BCH000977, BCH000979, BCH000985, BCH000987, BCH000989, BCH000991, BCH000993, BCH000994, BCH000995, BCH001004, BCH001005, BCH001007, BCH001009, BCH001010, BCH001011, BCH001015, BCH001016, BCH001025, BCH001035, BCH001036, BCH001040, BCH001042, BCH001043, BCH001044, BCH001045, BCH001047, BCH001049, BCH001056, BCH001063, BCH001065, BCH001072, BCH001086, BCH001091, BCH001103, BCH001109, BCH001110, BCH001111, BCH001112, BCH001114, BCH001117, BCH001118, BCH001119, BCH001121, BCH001129, BCH001134, BCH001136, BCH001142, BCH001152, BCH096768, BCH096770, BCH096771, BCH096773, BCH096775, BCH096779, BCH096782, BCH096785, BCH096787, BCH096789, BCH096790, BCH096791, BCH096794, BCH096796, BCH096799, BCH096800, BCH096801, BCH096804, BCH096805, BCH096806, BCH096811, BCH096812, BCH096813, BCH096818, BCH096820, BCH096821, BCH096822, BCH096827, BCH096828, BCH096830, BCH096832, BCH096833, BCH096836, BCH096850, BCH096924, BCH096936, BCH096947, BCH096954, BCH096956, BCH096959, BCH096962, BCH096963, BCH096964, BCH096967, BCH096968, BCH096969, BCH096972, BCH096973, BCH096974, BCH096975, BCH096976, BCH096977, BCH096978, BCH096979, BCH096981, BCH096983, BCH096984, BCH096985, BCH096986, BCH096987, BCH096989, BCH096990, BCH096992, BCH096993, BCH096994, BCH096996, BCH096997, BCH096998, BCH096999, BCH097001, BCH097003, BCH097004, BCH097005, BCH097006, BCH097007, BCH097010, BCH097012, BCH097013, BCH097014, BCH097015, BCH097016, BCH097017, BCH097020, BCH097021, BCH097022, BCH097051, BCH097052, BCH097053, BCH097054, BCH097055, BCH097056, BCH097060, BCH097061, BCH097066, BCH097067, BCH097068, BCH097069, BCH097070, BCH097075, BCH097076, BCH097078, BCH097079, BCH097083, BCH097088, BCH097091, BCH097092, BCH097094, BCH097096, BCH097098, BCH097100, BCH097101, BCH097103, BCH097104, BCH097107, BCH097110, BCH097112, BCH097113, BCH097114, BCH097117, BCH097120, BCH097122, BCH097123, BCH097125, BCH097129, BCH097131, BCH097132, BCH097134, BCH097135, BCH097137, BCH097199, BCH097201, BCH097202, BCH097206, BCH097208, BCH097209, BCH097210, BCH097211, BCH097212, BCH097213, BCH097214, BCH097215, BCH097217, BCH097218, BCH097219, BCH097222, BCH097224, BCH097225, BCH097226, BCH097227, BCH097228, BCH097230, BCH097232, BCH097233, BCH097235, BCH097236, BCH097237, BCH097238, BCH097240, BCH097241, BCH097243, BCH097244, BCH097245, BCH097246, BCH097249, BCH097250, BCH097254, BCH097255, BCH097257, BCH097259, BCH097260, BCH097263, BCH097264, BCH097265, BCH097269, BCH097272, BCH097273, BCH097275, BCH097279, BCH097312, BCH097328, BCH097359, BCH097363, BCH097370, BCH097374, BCH097375, BCH097382, BCH097383, BCH097385, BCH097387, BCH097388, BCH097392, BCH097395, BCH097397, BCH097398, BCH097400, BCH097404, BCH097405, BCH097406, BCH097407, BCH097408, BCH097409, BCH097411, BCH097418, BCH097419, BCH097420, BCH097425, BCH097426, BCH097428, BCH097429, BCH097430, BCH097431, bch097432, BCH097433, BCH097434, BCH097437, BCH097438, BCH097439, bch097440, BCH097441, BCH097443, bch097446, bch097447, bch097448, bch097449, bch097450, bch097451, bch097452, bch097453, BCH097454, bch097458, BCH097460, BCH097461, BCH097462, BCH097464, BCH097466, bch097467, bch097468, bch097470, BCH097472, BCH097473, BCH097474, BCH097475, BCH097477, BCH097478, BCH097480, BCH097482, BCH097484, BCH097485, BCH097488, BCH097489, BCH097490, BCH097491, BCH097492, BCH097495, BCH097496, BCH097497,
- Amount recalled
- 2031
Where it was sold
Why it was recalled
HVAD Battery Charger units manufactured with wrong inductors.
This product could cause temporary or reversible health problems — stop using it.
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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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