Exact FDA event identifier

Event 85397

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 03, 2020
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Heartware, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

Z-2055-2020

Recall number: Z-2055-2020
Initiated: April 03, 2020
Classification: Class I
Status: Ongoing
Recalling firm: Heartware, Inc.
Quantity: 2614 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Code information

GTIN 00888707000017, Serial Numbers: HW26899, HW27283, HW27893, HW28873, HW28999, HW29422, HW29488, HW29722, HW30166, HW30170 GTIN 00888707002639, Serial Numbers: HW29525, HW30015, HW30297, HW30477, HW31174, HW31179, HW31181, HW31246, HW31247, HW31250, HW31253, HW31257, HW31266, HW31268, hw31280, HW31281, hw31282, HW31283, HW31313, HW31385, HW31401, HW31497, HW31525, HW31526, HW31530, HW31531, HW31562, HW31567, HW31596, HW31597, HW31601, HW31602, HW31608, HW31609, HW31612, HW31624, HW31626, HW31634, HW31640, HW31641, HW31642, HW31643, HW31644, HW31645, HW31646, HW31647, HW31648, HW31649, HW31651, HW31652, HW31653, HW31655, HW31656, HW31657, HW31658, HW31659, HW31660, HW31661, HW31662, HW31663, HW31665, HW31666, HW31667, HW31668, HW31669, HW31670, HW31671, HW31672, HW31674, HW31675, HW31676, HW31677, HW31678, HW31679, HW31680, HW31681, HW31682, HW31687, HW31688, HW31689, HW31690, HW31691, HW31692, HW31693, HW31695, HW31696, HW31701, HW31705, HW31706, HW31707, HW31708, HW31709, HW31710, HW31711, HW31712, HW31713, HW31714, HW31716, HW31717, HW31719, HW31720, HW31721, HW31722, HW31723, HW31724, HW31725, HW31726, HW31728, HW31730, HW31732, HW31734, HW31736, HW31737, HW31738, HW31739, HW31740, HW31741, HW31742, HW31743, HW31744, HW31745, HW31746, HW31747, HW31748, HW31751, HW31752, HW31753, HW31754, HW31756, HW31757, HW31758, HW31760, HW31761, HW31762, HW31763, HW31764, HW31765, HW31766, HW31767, HW31768, HW31769, HW31770, HW31771, HW31772, HW31773, HW31774, HW31775, HW31776, HW31781, HW31782, HW31783, HW31784, HW31785, HW31786, HW31787, HW31788, HW31789, HW31790, HW31792, HW31793, HW31794, HW31796, HW31797, HW31798, HW31799, HW31800, HW31802, HW31803, HW31804, HW31805, HW31807, HW31816, HW31829, HW31841, HW31848, HW31850, HW31853, HW31854, HW31857, HW31861, HW31862, HW31864, HW31865, HW31866, HW31867, HW31868, HW31869, HW31870, HW31871, HW31878, HW31879, HW31880, HW31881, HW31882, HW31884, HW31885, HW31886, HW31887, HW31888, HW31889, HW31890, HW31894, HW31895, HW31896, HW31897, HW31898, HW31899, HW31900, HW31902, HW31904, HW31905, HW31906, HW31907, HW31910, HW31911, HW31913, HW31914, HW31916, HW31917, HW31918, HW31922, HW31923, HW31933, HW31935, HW31936, HW31938, HW31942, HW31943, HW31945, HW31946, HW31948, HW31949, HW31950, HW31951, HW31952, HW31953, HW31954, HW31956, HW31957, HW31959, HW31960, HW31961, HW31962, HW31963, HW31964, HW31965, HW31966, HW31967, HW31968, HW31969, HW31970, HW31971, HW31972, HW31974, HW31975, HW31977, HW31978, HW31980, HW31990, HW32003, HW32004, HW32005, HW32007, HW32016, HW32019, HW32020, HW32031, HW32033, HW32037, HW32041, HW32044, HW32045, HW32047, HW32048, HW32049, HW32051, HW32052, HW32054, HW32058, HW32059, HW32060, HW32061, HW32063, HW32066, HW32067, HW32069, HW32070, HW32072, HW32073, HW32074, HW32075, HW32076, HW32077, HW32078, HW32079, HW32080, HW32082, HW32083, HW32084, HW32087, HW32088, HW32089, HW32090, HW32091, HW32092, HW32093, HW32095, HW32096, HW32097, HW32098, HW32099, HW32100, HW32101, HW32104, HW32105, HW32106, HW32107, HW32110, HW32111, HW32114, HW32115, HW32117, HW32119, HW32120, HW32122, HW32126, HW32127, HW32128, HW32129, HW32130, HW32133, HW32134, HW32136, HW32137, HW32139, HW32140, HW32142, HW32145, HW32146, HW32148, HW32150, HW32151, HW32154, HW32155, HW32157, HW32158, HW32168, HW32169, HW32171, HW32173, HW32174, HW32176, HW32177, HW32178, HW32184, HW32185, HW32187, HW32188, HW32191, HW32196, HW32203, HW32208, HW32213, HW32225, HW32227, HW32233, HW32235, HW32237, HW32247, HW32249, HW32251, HW32252, HW32254, HW32262, HW32266, HW32267, HW32271, HW32272, HW32274, HW32275, HW32276, HW32277, HW32278, HW32280, HW32283, HW32284, HW32287, HW32288, HW32291, HW32293, HW32295, HW32296, HW32298, HW32299, HW32300, HW32302, HW32303, HW32304, HW32305, HW32306, HW32307, HW32308, HW32310, HW32311, HW32312, HW32313, HW32314, HW32316, HW32317, HW32318, HW32319, HW32320, HW32321, HW32322, HW32323, HW32324, HW32325, HW32326, HW32327, HW32328, HW32329, HW32330, HW32331, HW32332, HW32333, HW32334, HW32337, HW32338, HW32339, HW32340, HW32341, HW32343, HW32344, HW32345, HW32346, HW32348, HW32349, HW32350, HW32351, HW32352, HW32354, HW32355, HW32358, HW32359, HW32360, HW32361, HW32362, HW32363, HW32364, HW32365, HW32366, HW32367, HW32368, HW32370, HW32371, HW32372, HW32374, HW32375, HW32376, HW32377, HW32378, HW32379, HW32380, HW32381, HW32382, HW32383, HW32384, HW32387, HW32389, HW32390, HW32391, HW32392, HW32395, HW32396, HW32397, HW32398, HW32399, HW32401, HW32402, HW32403, HW32404, HW32405, HW32406, HW32409, HW32411, HW32412, HW32413, HW32414, HW32417, HW32418, HW32421, HW32422, HW32424, HW32425, HW32428, HW32429, HW32430, HW32431, HW32432, HW32433, HW32434, HW32436, HW32438, HW32439, HW32440, HW32441, HW32442, HW32443, HW32444, HW32446, HW32447, HW32448, HW32449, HW32450, HW32451, HW32452, HW32453, HW32454, HW32455, HW32456, HW32460, HW32461, HW32462, HW32463, HW32466, HW32467, HW32469, HW32475, HW32476, HW32477, HW32478, HW32480, HW32481, HW32482, HW32484, HW32485, HW32486, HW32487, HW32488, HW32489, HW32490, HW32491, HW32492, HW32493, HW32494, HW32495, HW32496, HW32497, HW32498, HW32500, HW32501, HW32502, HW32503, HW32512, HW32526, HW32527, HW32528, HW32529, HW32530, HW32531, HW32532, HW32533, HW32535, HW32536, HW32537, HW32538, HW32539, HW32540, HW32541, HW32542, HW32543, HW32544, HW32545, HW32547, HW32549, HW32550, HW32551, HW32552, HW32553, HW32555, HW32556, HW34011, HW34013, HW34014, HW34016, HW34032, HW34055, HW34057, HW34058, HW34059, HW34061, HW34063, HW34064, HW34065, HW34067, HW34070, HW34071, HW34073, HW34074, HW34076, HW34077, HW34079, HW34080, HW34081, HW34082, HW34083, HW34085, HW34087, HW34089, HW34097, HW34098, HW34099, HW34101, HW34102, HW34103, HW34105, HW34108, HW34112, HW34114, HW34116, HW34118, HW34119, HW34127, HW34128, HW34130, HW34131, HW34133, HW34134, HW34135, HW34136, HW34137, HW34138, HW34139, HW34140, HW34141, HW34142, HW34143, HW34144, HW34145, HW34146, HW34147, HW34153, HW34154, HW34155, HW34156, HW34157, HW34158, HW34159, HW34160, HW34162, HW34163, HW34164, HW34165, HW34166, HW34167, HW34168, HW34170, HW34171, HW34172, HW34173, HW34174, HW34175, HW34176, HW34177, HW34178, HW34183, HW34185, HW34188, HW34189, HW34190, HW34194, HW34195, HW34198, HW34199, HW34200, HW34201, HW34203, HW34212, HW34213, HW34214, HW34215, HW34216, HW34217, HW34218, HW34219, HW34220, HW34221, HW34222, HW34223, HW34224, HW34225, HW34227, HW34228, HW34230, HW34231, HW34233, HW34234, HW34235, HW34236, HW34238, HW34239, HW34240, HW34241, HW34242, HW34243, HW34244, HW34245, HW34246, HW34247, HW34248, HW34249, HW34250, HW34253, HW34254, HW34255, HW34256, HW34257, HW34258, HW34259, HW34260, HW34261, HW34262, HW34263, HW34264, HW34265, HW34267, HW34276, HW34279, HW34282, HW34284, HW34285, HW34286, HW34287, HW34288, HW34289, HW34291, HW34294, HW34295, HW34297, HW34298, HW34299, HW34300, HW34302, HW34303, HW34304, HW34305, HW34306, HW34307, HW34308, HW34310, HW34311, HW34312, HW34313, HW34314, HW34315, HW34316, HW34318, HW34320, HW34321, HW34322, HW34323, HW34325, HW34332, HW34333, HW34334, HW34335, HW34338, HW34339, HW34353, HW34360, HW34385, HW34386, HW34387, HW34389, HW34390, HW34391, HW34392, HW34393, HW34394, HW34396, HW34397, HW34399, HW34400, HW34402, HW34403, HW34404, HW34405, HW34406, HW34407, HW34409, HW34410, HW34411, hw34413, hw34416, hw34417, HW34422, HW34423, HW34424, HW34430, HW34435, HW34441, HW34445, HW34447, HW34450, HW34451, HW34453, HW34455, HW34457, HW34458, HW34459, HW34460, HW34462, HW34463, HW34464, HW34465, HW34466, HW34467, HW34468, HW34469, HW34470, HW34471, HW34472, HW34473, HW34475, HW34476, HW34477, HW34479, HW34480, HW34481, HW34482, HW34483, HW34485, HW34486, HW34487, HW34488, HW34489, HW34492, HW34493, HW34494, HW34496, HW34498, HW34499, HW34500, HW34501, HW34502, HW34503, HW34504, HW34505, HW34506, HW34515, HW34525, HW34526, HW34527, HW34528, HW34529, HW34530, HW34531, HW34532, HW34533, HW34534, HW34535, HW34537, HW34538, HW34540, HW34541, HW34542, HW34543, HW34544, HW34545, HW34548, HW34549, HW34552, HW34553, HW34554, HW34558, HW34562, HW34564, HW34565, HW34566, HW34567, HW34568, HW34570, HW34571, HW34572, HW34573, HW34574, HW34575, HW34576, HW34577, HW34578, HW34579, HW34580, HW34581, HW34583, HW34584, HW34585, HW34587, HW34589, HW34592, HW34593, HW34597, HW34598, HW34599, HW34600, HW34601, HW34602, HW34604, HW34606, HW34608, HW34611, HW34612, HW34613, HW34614, HW34616, HW34626, HW34627, HW34632, HW34633, HW34634, HW34635, HW34638, HW34639, HW34640, HW34642, HW34644, HW34645, HW34646, HW34647, HW34648, HW34649, HW34650, HW34651, HW34652, HW34653, HW34654, HW34655, HW34657, HW34658, HW34659, HW34660, HW34661, HW34662, HW34663, HW34665, HW34667, HW34668, HW34669, HW34671, HW34672, HW34674, HW34675, HW34676, HW34677, HW34678, HW34679, HW34680, HW34681, HW34683, HW34684, HW34685, HW34686, HW34687, HW34688, HW34689, HW34690, HW34695, HW34696, HW34697, HW34698, HW34699, HW34701, HW34702, HW34705, HW34706, HW34707, HW34708, HW34709, HW34712, HW34714, HW34715, HW34716, HW34718, HW34721, HW34722, HW34725, HW34728, HW34729, HW34730, HW34731, HW34733, HW34735, HW34736, HW34740, HW34741, HW34744, HW34747, HW34754, HW34755, HW34756, HW34760, HW34763, HW34765, HW34766, HW34770, HW34771, HW34772, HW34773, HW34774, HW34775, HW34777, HW34778, HW34780, HW34781, HW34782, HW34783, HW34784, HW34786, HW34787, HW34788, HW34789, HW34790, HW34793, HW34794, HW34795, HW34796, HW34797, HW34798, HW34799, HW34800, HW34804, HW34807, HW34809, HW34811, HW34812, HW34814, HW34815, HW34816, HW34819, HW34820, HW34821, HW34822, HW34823, HW34825, HW34826, HW34827, HW34828, HW34830, HW34831, HW34832, HW34835, HW34843, HW34852, HW34854, HW34856, HW34857, HW34858, HW34859, HW34860, HW34861, HW34863, HW34865, HW34869, HW34870, HW34871, HW34872, HW34874, HW34878, HW34883, HW34887, HW34891, HW34896, HW34899, HW34917, HW34918, HW34921, HW34922, HW34926, HW34927, HW34929, HW34930, HW34931, HW34935, HW34937, HW34942, HW34943, HW34952, HW34956, HW34958, HW34961, HW34962, HW34964, HW34967, HW34969, HW34970, HW34971, HW34972, HW34973, HW34976, HW34978, HW34980, HW34981, HW34983, HW34984, HW34987, HW34988, HW34989, HW34993, HW34995, HW34998, HW34999, HW35001, HW35003, HW35004, HW35005, HW35006, HW35007, HW35008, HW35009, HW35010, HW35011, HW35013, HW35014, HW35015, HW35017, HW35018, HW35020, HW35022, HW35023, HW35026, HW35027, HW35029, HW35030, HW35036, HW35037, HW35042, HW35044, HW35045, HW35046, HW35047, HW35048, HW35050, HW35051, HW35053, HW35055, HW35058, HW35059, HW35060, HW35063, HW35066, HW35069, HW35071, HW35072, HW35073, HW35074, HW35075, HW35076, HW35077, HW35078, HW35079, HW35081, HW35082, HW35084, HW35087, HW35088, HW35089, HW35092, HW35096, HW35098, HW35100, HW35101, HW35103, HW35104, HW35105, HW35106, HW35107, HW35109, HW35110, HW35111, HW35112, HW35113, HW35115, HW35116, HW35117, HW35118, HW35126, HW35129, HW35130, HW35132, HW35135, HW35140, HW35152, HW35153, HW35159, HW35160, HW35163, HW35165, HW35166, HW35167, HW35168, HW35169, HW35170, HW35172, HW35173, HW35174, HW35175, HW35176, HW35177, HW35178, HW35179, HW35180, HW35181, HW35182, HW35183, HW35184, HW35190, HW35192, HW35193, HW35194, HW35195, HW35198, HW35199, HW35203, HW35206, HW35219, HW35221, HW35222, HW35223, HW35224, HW35225, HW35226, HW35227, HW35229, HW35231, HW35232, HW35233, HW35234, HW35235, HW35236, HW35238, HW35239, HW35240, HW35241, HW35242, HW35243, HW35244, HW35245, HW35246, HW35247, HW35249, HW35253, HW35254, HW35255, HW35256, HW35257, HW35258, HW35259, HW35261, HW35262, HW35263, HW35264, HW35265, HW35266, HW35267, HW35268, HW35269, HW35270, HW35271, HW35273, HW35274, HW35276, HW35277, HW35280, HW35285, HW35286, HW35287, HW35288, HW35289, HW35291, HW35292, HW35293, HW35294, HW35295, HW35296, HW35299, HW35301, HW35302, HW35347, HW35354, HW35358, HW35399, HW35403, HW35406, HW35410, HW35413, HW35414, HW35415, HW35416, HW35417, HW35420, HW35422, HW35424, HW35425, HW35426, HW35427, HW35428, HW35429, HW35430, HW35431, HW35433, HW35434, HW35435, HW35436, HW35437, HW35438, HW35439, HW35440, HW35441, HW35442, HW35443, HW35444, HW35445, HW35446, HW35447, HW35448, HW35449, HW35450, HW35451, HW35452, HW35453, HW35454, HW35455, HW35456, HW35457, HW35459, HW35460, HW35461, HW35462, HW35463, HW35466, HW35469, HW35471, HW35472, HW35473, HW30051, HW30066, HW30169, HW30330, HW30573, HW30605, HW30613, HW30628, HW30677, HW30700, HW30703, HW30884, HW30904, HW30912, HW30992, HW30999, HW31004, HW31013, HW31038, HW31046, HW31053, HW31060, HW31149, HW31151, HW31199, HW31225, HW31230, HW31321, HW31367, HW31407, HW31463, HW31537 GTIN 00888707003261, Serial Numbers: HW40002, HW40004, HW40006, HW40008, HW40009, HW40010, HW40012, HW40013, HW40015, HW40016, HW40017, HW40018, HW40019, HW40021, HW40022, HW40023, HW40024, HW40025, HW40026, HW40028, HW40030, HW40032, HW40033, HW40035, HW40036, HW40037, HW40038, HW40039, HW40041, HW40042, HW40043, HW40044, HW40045, HW40046, HW40047, HW40048, HW40049, HW40050, HW40051, HW40054, HW40055, HW40057, HW40058, HW40059, HW40060, HW40061, HW40062, HW40063, HW40064, HW40065, HW40066, HW40067, HW40068, HW40069, HW40070, HW40071, HW40072, HW40073, HW40074, HW40075, HW40076, HW40077, HW40078, HW40079, HW40080, HW40081, HW40082, HW40083, HW40084, HW40085, HW40086, HW40087, HW40088, HW40089, HW40090, HW40091, HW40092, HW40093, HW40094, HW40095, HW40096, HW40097, HW40098, HW40099, HW40100, HW40102, HW40103, HW40105, HW40106, HW40107, HW40108, HW40109, HW40110, HW40111, HW40112, HW40113, HW40114, HW40115, HW40116, HW40117, HW40118, HW40119, HW40120, HW40121, HW40122, HW40123, HW40124, HW40125, HW40126, HW40127, HW40128, HW40129, HW40130, HW40131, HW40132, HW40135, HW40136, HW40137, HW40138, HW40139, HW40140, HW40142, HW40143, HW40144, HW40145, HW40146, HW40147, HW40148, HW40149, HW40150, HW40151, HW40152, HW40153, HW40154, HW40155, HW40156, HW40157, HW40158, HW40159, HW40160, HW40161, HW40163, HW40164, HW40165, HW40166, HW40167, HW40168, HW40169, HW40170, HW40171, HW40172, HW40174, HW40175, HW40176, HW40177, HW40178, HW40179, HW40180, HW40181, HW40182, HW40184, HW40185, HW40186, HW40187, HW40188, HW40189, HW40190, HW40191, HW40192, HW40193, HW40194, HW40195, HW40196, HW40197, HW40198, HW40199, HW40200, HW40201, HW40202, HW40203, HW40204, HW40206, HW40207, HW40208, HW40209, HW40210, HW40211, HW40212, HW40213, HW40214, HW40215, HW40217, HW40218, HW40219, HW40220, HW40222, HW40223, HW40224, HW40225, HW40226, HW40227, HW40228, HW40229, HW40230, HW40231, HW40232, HW40233, HW40234, HW40235, HW40236, HW40237, HW40238, HW40239, HW40240, HW40241, HW40242, HW40243, HW40244, HW40245, HW40246, HW40247, HW40248, HW40249, HW40250, HW40251, HW40252, HW40253, HW40254, HW40255, HW40256, HW40257, HW40258, HW40259, HW40260, HW40261, HW40262, HW40263, HW40264, HW40265, HW40266, HW40267, HW40268, HW40269, HW40270, HW40271, HW40272, HW40273, HW40274, HW40275, HW40276, HW40277, HW40278, HW40279, HW40280, HW40281, HW40282, HW40283, HW40284, HW40285, HW40286, HW40287, HW40288, HW40289, HW40290, HW40291, HW40292, HW40293, HW40294, HW40295, HW40296, HW40297, HW40298, HW40299, HW40300, HW40301, HW40302, HW40303, HW40304, HW40305, HW40306, HW40307, HW40308, HW40309, HW40310, HW40311, HW40312, HW40313, HW40314, HW40315, HW40316, HW40317, HW40318, HW40319, HW40320, HW40321, HW40322, HW40323, HW40324, HW40325, HW40326, HW40327, HW40328, HW40329, HW40330, HW40331, HW40332, HW40333, HW40334, HW40335, HW40337, HW40338, HW40339, HW40340, HW40341, HW40359, HW40360, HW40361, HW40362, HW40364, HW40371, HW40372, HW40373, HW40375, HW40376, HW40377, HW40378, HW40379, HW40380, HW40381, HW40382, HW40384, HW40385, HW40386, HW40387, HW40388, HW40389, HW40390, HW40391, HW40392, HW40393, HW40394, HW40395, HW40396, HW40397, HW40399, HW40400, HW40401, HW40402, HW40403, HW40404, HW40405, HW40406, HW40407, HW40408, HW40409, HW40410, HW40411, HW40432, HW40433, HW40434, HW40435, HW40436, HW40437, HW40438, HW40440, HW40441, HW40442, HW40443, HW40444, HW40445, HW40446, HW40447, HW40448, HW40449, HW40451, HW40452, HW40453, HW40454, HW40455, HW40456, HW40457, HW40460, HW40461, HW40462, HW40463, HW40464, HW40466, HW40467, HW40468, HW40469, HW40470, HW40481, HW40482, HW40483, HW40484, HW40485, HW40486, HW40487, HW40488, HW40489, HW40490, HW40491, HW40492, HW40493, HW40494, HW40496, HW40497, HW40498, HW40499, HW40500, HW40501, HW40502, HW40503, HW40504, HW40505, HW40506, HW40507, HW40508, HW40509, HW40510, HW40511, HW40512, HW40513, HW40514, HW40515, HW40516, HW40517, HW40518, HW40519, HW40520, HW40521, HW40522, HW40523, HW40524, HW40525, HW40526, HW40527, HW40528, HW40529, HW40530, HW40531, HW40532, HW40533, HW40534, HW40535, HW40536, HW40537, HW40538, HW40539, HW40540, HW40541, HW40542, HW40543, HW40544, HW40545, HW40546, HW40547, HW40548, HW40549, HW40550, HW40551, HW40558, HW40559, HW40560, HW40561, HW40562, HW40563, HW40566, HW40567, HW40568, HW40569, HW40570, HW40571, HW40572, HW40573, HW40574, HW40575, HW40576, HW40577, HW40578, HW40581, HW40582, HW40583, HW40584, HW40585, HW40589, HW40590, HW40591, HW40592, HW40593, HW40594, HW40595, HW40596, HW40597, HW40598, HW40601, HW40605, HW40606, HW40610, HW40616, HW40617, HW40620, HW40621, HW40622, HW40623, HW40627, HW40628, HW40629, HW40630, HW40631, HW40633, HW40634, HW40635, HW40636, HW40637, HW40638, HW40639, HW40640, HW40641, HW40642, HW40643, HW40644, HW40645, HW40646, HW40647, HW40648, HW40671, HW40672, HW40673, HW40674, HW40676, HW40677, HW40678, HW40679, HW40680, HW40681, HW40682, HW40683, HW40684, HW40685, HW40686, HW40687, HW40688, HW40689, HW40690, HW40691, HW40692, HW40693, HW40694, HW40695, HW40696, HW40697, HW40698, HW40699, HW40700, HW40703, HW40704, HW40705, HW40706, HW40707, HW40708, HW40709, HW40710, HW40711, HW40712, HW40713, HW40714, HW40715, HW40716, HW40717, HW40718, HW40719, HW40720, HW40721, HW40722, HW40723, HW40724, HW40725, HW40726, HW40727, HW40728, HW40729, HW40730, HW40731, HW40732, HW40733, HW40734, HW40735, HW40736, HW40737, HW40738, HW40739, HW40740, HW40741, HW40742, HW40743, HW40744, HW40745, HW40746, HW40747, HW40748, HW40749, HW40750, HW40751, HW40752, HW40753, HW40754, HW40755, HW40756, HW40757, HW40758, HW40759, HW40760, HW40761, HW40762, HW40763, HW40764, HW40766, HW40767, HW40768, HW40769, HW40770, HW40771, HW40772, HW40773, HW40774, HW40775, HW40776, HW40777, HW40778, HW40779, HW40780, HW40781, HW40783, HW40784, HW40785, HW40786, HW40790, HW40791, HW40792, HW40793, HW40794, HW40795, HW40796, HW40797, HW40798, HW40799, HW40800, HW40801, HW40802, HW40803, HW40804, HW40805, HW40806, HW40807, HW40808, HW40809, HW40810, HW40811, HW40812, HW40813, HW40814, HW40815, HW40817, HW40818, HW40819, HW40820, HW40821, HW40822, HW40823, HW40824, HW40825, HW40826, HW40827, HW40828, HW40829, HW40830, HW40831, HW40832, HW40833, HW40834, HW40837, HW40838, HW40839, HW40840, HW40841, HW40857, HW40858, HW40859, HW40860, HW40861, HW40862, HW40863, HW40864, HW40865, HW40866, HW40867, HW40868, HW40869, HW40870, HW40872, HW40873, HW40874, HW40875, HW40876, HW40877, HW40878, HW40879, HW40880, HW40882, HW40883, HW40884, HW40885, HW40886, HW40887, HW40888, HW40889, HW40890, HW40891, HW40892, HW40893, HW40894, HW40896, HW40897, HW40899, HW40902, HW40903, HW40904, HW40905, HW40906, HW40907, HW40908, HW40910, HW40911, HW40912, HW40913, HW40914, HW40915, HW40916, HW40917, HW40918, HW40919, HW40920, HW40921, HW40922, HW40923, HW40924, HW40925, HW40926, HW40927, HW40928, HW40929, HW40930, HW40931, HW40932, HW40933, HW40935, HW40936, HW40937, HW40939, HW40940, HW40941, HW40942, HW40943, HW40944, HW40946, HW40947, HW40948, HW40949, HW40962, HW40963, HW40964, HW40965, HW40966, HW40967, HW40968, HW40969, HW40970, HW40971, HW40972, HW40973, HW40974, HW40975, HW40976, HW40977, HW40979, HW40982, HW40983, HW40984, HW40985, HW40986, HW40987, HW40988, HW40989, HW40990, HW40991, HW40992, HW40993, HW40994, HW40995, HW40996, HW40997, HW40998, HW40999, HW41001, HW41002, HW41004, HW41005, HW41006, HW41007, HW41008, HW41009, HW41010, HW41011, HW41012, HW41014, HW41015, HW41016, HW41017, HW41018, HW41019, HW41020, HW41021, HW41022, HW41023, HW41024, HW41025, HW41027, HW41029, HW41030, HW41031, HW41032, HW41033, HW41034, HW41035, HW41037, HW41038, HW41039, HW41040, HW41042, HW41043, HW41044, HW41046, HW41051, HW41052, HW41053, HW41054, HW41055, HW41057, HW41058, HW41059, HW41060, HW41061, HW41062, HW41063, HW41064, HW41065, HW41066, HW41067, HW41068, HW41069, HW41070, HW41071, HW41072, HW41073, HW41075, HW41076, HW41077, HW41078, HW41080, HW41081, HW41084, HW41086, HW41088, HW41089, HW41090, HW41091, HW41092, HW41093, HW41097, HW41098, HW41099, HW41100, HW41102, HW41103, HW41104, HW41105, HW41106, HW41107, HW41108, HW41111, HW41112, HW41115, HW41118, HW41119, HW41120, HW41121, HW41122, HW41123, HW41124, HW41125, HW41126, HW41127, HW41128, HW41130, HW41131, HW41132, HW41133, HW41135, HW41136, HW41137, HW41138, HW41139, HW41140, HW41141, HW41142, HW41143, HW41144, HW41145, HW41146, HW41147, HW41148, HW41149, HW41150, HW41152, HW41153, HW41154, HW41155, HW41157, HW41158, HW41159, HW41160, HW41161, HW41162, HW41164, HW41165, HW41166, HW41167, HW41168, HW41169, HW41170, HW41171, HW41172, HW41173, HW41174, HW41176, HW41177, HW41178, HW41179, HW41180, HW41181, HW41182, HW41184, HW41185, HW41186, HW41187, HW41188, HW41189, HW41190, HW41193, HW41194, HW41195, HW41196, HW41197, HW41198, HW41199, HW41200, HW41201, HW41202, HW41203, HW41204, HW41205, HW41206, HW41207, HW41208, HW41210, HW41212, HW41213, HW41215, HW41216, HW41217, HW41218, HW41219, HW41220, HW41221, HW41223, HW41224, HW41225, HW41226, HW41227, HW41228, HW41229, HW41230, HW41231, HW41232, HW41233, HW41234, HW41235, HW41236, HW41237, HW41238, HW41239, HW41241, HW41242, HW41243, HW41244, HW41245, HW41246, HW41247, HW41248, HW41249, HW41250, HW41267, HW41268, HW41272, HW41273, HW41274, HW41275, HW41276, HW41277, HW41278, HW41279, HW41280, HW41281, HW41282, HW41283, HW41284, HW41285, HW41286, HW41287, HW41288, HW41289, HW41291, HW41293, HW41294, HW41295, HW41296, HW41297, HW41298, HW41299, HW41300, HW41301, HW41302, HW41303, HW41304, HW41305, HW41307, HW41310, HW41312, HW41318, HW41319, HW41320, HW41321, HW41322, HW41323, HW41324, HW41325, HW41326, HW41327, HW41329, HW41330, HW41331, HW41332, HW41333, HW41334, HW41336, HW41337, HW41338, HW41339, HW41341, HW41343, HW41344, HW41345, HW41346, HW41347, HW41348, HW41349, HW41350, HW41351, HW41352, HW41354, HW41355, HW41357, HW41358, HW41359, HW41360, HW41361, HW41362, HW41363, HW41364, HW41368, HW41369, HW41371, HW41372, HW41373, HW41374, HW41376, HW41377, HW41378, HW41379, HW41380, HW41381, HW41382, HW41383, HW41384, HW41385, HW41386, HW41387, HW41388, HW41389, HW41390, HW41391, HW41392, HW41393, HW41394, HW41395, HW41396, HW41398, HW41399, HW41400, HW41401, HW41402, HW41404, HW41405, HW41406, HW41407, HW41408, HW41409, HW41410, HW41412, HW41413, HW41414, HW41415, HW41416, HW41417, HW41418, HW41419, HW41420, HW41422, HW41423, HW41424, HW41425, HW41426, HW41427, HW41428, HW41429, HW41430, HW41431, HW41432, HW41433, HW41434, HW41435, HW41436, HW41437, HW41438, HW41439, HW41440, HW41441, HW41442, HW41443, HW41444, HW41445, HW41446, HW41447, HW41448, HW41449, HW41450, HW41452, HW41453, HW41454, HW41455, HW41456, HW41458, HW41459, HW41460, HW41461, HW41462, HW41463, HW41465, HW41466, HW41467, HW41468, HW41469, HW41470, HW41471, HW41472, HW41473, HW41474, HW41475, HW41476, HW41477, HW41478, HW41479, HW41480, HW41481, HW41482, HW41483, HW41484, HW41486, HW41488, HW41489, HW41490, HW41491, HW41492, HW41493, HW41494, HW41495, HW41496, HW41497, HW41498, HW41499, HW41500, HW41502, HW41503, HW41504, HW41505, HW41506, HW41507, HW41508, HW41509, HW41644, HW41645, HW41646, HW41648, HW41649, HW41650, HW41651, HW41653, HW41654

Distribution pattern

Worldwide Distribution

device · product 2 of 5

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

Z-2056-2020

Recall number: Z-2056-2020
Initiated: April 03, 2020
Classification: Class I
Status: Ongoing
Recalling firm: Heartware, Inc.
Quantity: 2225 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Code information

GTIN 00888707002028, Serial Numbers: HW28848, hw29011, HW29154, HW29211, HW29248, HW29249, HW29273, HW29329, HW29426, HW29465, HW29472, HW29522, HW29534, HW29548, HW29549, HW29567, HW29588, HW29593, HW29602, HW29612, HW29667, HW29700, HW29786, HW29815, HW29915, HW29928, HW29949, HW30039, HW30082, HW30083, HW30150, HW30153, HW30208, HW30211, HW30226, HW30320, HW30342, HW30358, HW30360, HW30363, HW30378, HW30380, HW30382, HW30390, HW30398, HW30400, HW30402, HW30406, HW30410, HW30430, HW30475, HW30484, HW30494, HW30498, HW30595, HW30596, HW30597, HW30601, HW30604, HW30651, HW30768, HW30769, HW30770, HW30771, HW30814, HW30821, HW30829, HW30863, HW30865, HW30867, HW30871, HW30953, HW30961, HW30962, HW30966, HW30971, HW30972, HW30974, HW31020, HW31076, HW31101, HW31103, HW31104, HW31107, HW31113, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31232, HW31235, HW31242, HW31244, HW31249, HW31254, HW31255, HW31260, HW31261, HW31262, HW31267, HW31383, HW31387, HW31388, HW31399, 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, HW32474, 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, HW35127, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35142, 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 GTIN 00888707002387, Serial Numbers: HW28851, HW29783, HW29793, HW29794, HW29827, HW29870, HW29918, HW30045, HW30046, HW30505, HW30765, HW30842, HW30844, HW30845, HW30846, hw30978, HW31075, HW31077, HW31080, hw31089, hw31091, HW31095, HW31161, HW31342, HW31348, HW31555, HW31556, HW31557, HW31683, HW31860, HW31903, HW31920, HW31924, HW31926, HW32026, HW32027, HW32028, HW32149, HW32153, HW32163, HW32282, HW32513, HW32514, HW32562, HW32563, HW34004, HW34006, HW34091, HW34092, HW34125, HW34272, HW34273, HW34274, HW34349, HW34350, HW34351, HW34352, HW34357, HW34358, HW34359, HW34366, HW34374, HW34436, HW34953, HW34968, HW35080, HW35144, HW35145, HW35148, HW35327, HW35342, HW35344, HW35537, HW35596, HW35603, HW35604, HW35605, HW35606, HW35607, HW35713, HW35714, HW35717, HW35718, HW35721, HW35723 GTIN 00888707001649, Serial Numbers: HW29132, HW29232, hw29653, HW29682, HW29684, HW29705, HW29864, HW29985, HW29991, HW30096, HW30100, HW30145, HW30146, HW30373, HW30374, HW30421, HW30525, HW30529, HW30726, HW30738, HW30836, HW30840, HW30862, HW30939, hw30949, hw30950, HW31048, HW31071, HW31082, HW31088, hw31133, hw31394, HW31415, HW31417, HW31420, HW31421, HW31423, hw31483, hw31505, hw31506, hw31507, hw31510, HW31511, hw31512, hw31513, hw31515, hw31516, hw31517, HW31546, HW31551, HW31554, HW31566, HW31587, HW31588, HW31589, HW31590, HW31592, HW31632, HW31639, HW31685, HW31795, HW31801, HW31806, HW31808, HW31809, HW31811, HW31812, HW31813, HW31815, HW31891, HW31892, HW31893, HW31919, HW31921, HW31973, HW31982, HW31985, HW32000, HW32001, HW32014, HW32015, HW32018, HW32021, HW32022, HW32024, HW32042, HW32050, HW32055, HW32056, HW32064, HW32081, HW32094, HW32112, HW32123, HW32138, HW32147, HW32186, HW32245, HW32255, HW32264, HW32265, HW32268, HW32270, HW32301, HW32394, HW32410, HW32420, HW32558, HW32559, HW32560, HW32561, HW34029, HW34031, HW34093, HW34094, HW34132, HW34148, HW34180, HW34266, HW34268, HW34269, HW34270, HW34271, HW34296, HW34301, HW34324, HW34327, HW34340, HW34341, HW34343, HW34345, HW34346, HW34348, HW34418, HW34420, HW34431, HW34507, HW34508, HW34641, HW34692, HW34745, HW34764, HW34836, HW34906, HW34932, HW34936, HW34940, HW34941, HW34963, HW34977, HW34992, HW34994, HW35019, HW35021, HW35033, HW35035, HW35038, HW35041, HW35065, HW35068, HW35085, HW35090, HW35094, HW35114, HW35147, HW35157, HW35196, HW35197, HW35210, HW35237, HW35250, HW35290, HW35308, HW35309, HW35310, HW35311, HW35312, HW35313, HW35314, HW35315, HW35318, HW35320, HW35328, HW35329, HW35330, HW35333, HW35338, HW35349, HW35365, HW35366, HW35368, HW35370, HW35371, HW35372, HW35373, HW35375, HW35378, HW35402, HW35404, HW35405, HW35408, HW35409, HW35411, HW35412, HW35418, HW35421, HW35423, HW35465, HW35470, HW35475, HW35476, HW35485, HW35486, HW35546, HW35547, HW35550, HW35551, HW35552, HW35553, HW35554, HW35555, HW35556, HW35557, HW35558, HW35559, HW35560, HW35564, HW35598, HW35599, HW35602, HW35640, HW35657, HW35658, HW35659, HW35662, HW35663, HW35664, HW35665, HW35666, HW35667, HW35672, HW35694, HW35719, HW35750, HW35753, HW36121, HW36154, HW36165, HW36168 GTIN 00888707000581, Serial Numbers: HW29203, HW29425, HW29427, HW29428, HW29430, HW29439, HW29517, HW29679, HW29680, HW30589, HW30638, HW30706, HW30876, HW31144, HW31187, hw31376, hw31380, HW31442, HW31727, HW31998, HW32023, HW32416, HW34017 GTIN 00888707002417, Serial Numbers: HW29478, HW30381, HW30831, HW34380, HW34421, HW35348, HW35613, HW35756, HW35761, HW35763 GTIN 00888707002493, Serial Numbers: HW29483, HW29697, HW29698, hw31178, HW31520, HW31821, HW31823, HW31827, HW32086, HW32242, HW32246, HW32518, HW32519, HW34021, HW34365, HW34367, HW34792, HW34915, HW35155, HW35158, HW35252, HW35343, HW35345, HW35346, HW35350, HW35400, HW35401, HW35529, HW35530, HW35574, HW35591, HW35660, HW35661, HW35785 GTIN 00888707002400, Serial Numbers: HW29518, HW29693, HW30092, HW32257, HW34012, HW34210, HW35034, HW35154, HW35573, HW35653 GTIN 00888707002547, Serial Numbers: HW29561, HW29601, HW29931, HW30502, HW30593, HW30619, HW30632, HW30783, HW30796, HW30819, HW30826, HW31136, HW31140, HW31141, HW31156, HW31157, HW31158, HW31382, HW31393, HW31406, HW31408, HW31413, HW31416, HW31426, HW31429, HW31553, HW31791, HW31937, HW31994, HW32118, HW32269, HW32309, HW32336, HW32347, HW32373, HW32385, HW32522, HW32523, HW32524, HW32554, HW32557, HW34003, HW34007, HW34008, HW34049, HW34050, HW34053, HW34054, HW34382, HW34383, HW34513, HW34514, HW34516, HW34517, HW34518, HW35251, HW35275 GTIN 00888707000680, Serial Numbers: HW29571, HW29578, HW29845, HW30635, HW30639, HW30711, HW31150 GTIN 00888707002394, Serial Numbers: HW30469, HW30506, HW30508, HW30509, HW30510, HW30511, HW30512, HW30655, HW31580, HW31582, HW31583, HW31584, HW31992, HW31993, HW32200, HW32207, HW32217, HW32238, HW32239, HW32240, HW32515, HW32517, HW34022, HW34023, HW34395, HW34461, HW34557, HW34561, HW34582, HW34751, HW34950, HW34955, HW34991, HW34996, HW35016, HW35149, HW35150, HW35186, HW35336, HW35386, HW35397, HW35484, HW35509, HW35510, HW35538, HW35566, HW35609, HW35610, HW35611, HW35648, HW35649, HW35651, HW35679, HW35699, HW35700, HW35706, HW35776, HW35779 GTIN 00888707000239, Serial Numbers: HW30634, HW30645, HW30877, HW34737 GTIN 00888707002530, Serial Numbers: HW30797, HW31108, HW31440, HW31828, HW31928, HW32182, HW32253, HW32263, HW34559, HW35000, HW35162, HW35532, HW35533, HW35590 GTIN 00888707002523, Serial Numbers: HW30859, HW31703, HW31704, HW31859, HW32030, HW32036, HW32040, HW32102, HW32520, HW32521, HW34018, HW34020, HW34027, HW34028, HW34986, HW35040, HW35043, HW35049, HW35216, HW35217, HW35218, HW35490, HW35531, HW35619, HW35786 GTIN 00888707002431, Serial Numbers: hw30979, hw31123, HW32029, HW32180, HW34024, HW34381, HW34615, HW35119, HW35733 GTIN 00888707002585, Serial Numbers: hw31079, hw31081, hw31168, hw31170, HW35095, HW35164, HW35351, HW35353, HW35355, HW35496, HW35497, HW35575, HW35576 GTIN 00888707002516, Serial Numbers: hw31147, hw31162, HW32507, HW34524, HW35474 GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36007, HW36008, HW36009, HW36010, HW36013, HW36014, HW36015, HW36018, HW36019, HW36020, HW36021, HW36067, HW36068, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36182, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36196, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36249, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36306, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36337, 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, HW36420, 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, HW36558, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36632, HW36633, HW36636, HW36637, HW36655, HW36659, HW36660, HW36662, HW36663, HW36664, HW36669, HW36670, HW36671, HW36672, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36853, HW36854, HW36855, HW36898, HW36899, HW36900, HW36903, HW36919, HW36921 GTIN 00888707002486, Serial Numbers: HW31444, HW31569, HW31673, HW31814, HW31817, HW31818, HW31820, HW31824, HW31825, HW31826, HW31872, HW31873, HW31875, HW31877, HW31927, HW31932, HW31934, HW31939, HW31940, HW31941, HW31995, HW31996, HW31997, HW31999, HW32002, HW32008, HW32009, HW32010, HW32011, HW32013, HW32032, HW32034, HW32038, HW32046, HW32053, HW32057, HW32062, HW32065, HW32071, HW32085, HW32109, HW32165, HW32166, HW32195, HW32205, HW32211, HW32221, HW32236, HW32243, HW32250, HW32506, HW34015, HW34122, HW34123, HW34124, HW34251, HW34252, HW34275, HW34277, HW34280, HW34354, HW34355, HW34356, HW34361, HW34364, HW34433, HW34434, HW34437, HW34439, HW34440, HW34442, HW34443, HW34444, HW34452, HW34454, HW34619, HW34620, HW34621, HW34622, HW34623, HW34624, HW34629, HW34630, HW34631, HW34636, HW34656, HW34719, HW34738, HW34739, HW34742, HW34748, HW34749, HW34750, HW34753, HW34757, HW34758, HW34761, HW34762, HW34767, HW34769, HW34779, HW34818, HW34853, HW34867, HW34873, HW34879, HW34880, HW34882, HW34885, HW34888, HW34890, HW34897, HW34898, HW34900, HW34905, HW34909, HW34911, HW34912, HW34945, HW34954, HW34960, HW35171, HW35228, HW35230, HW35278, HW35282, HW35283, HW35297, HW35298, HW35300, HW35303, HW35304, HW35306, HW35307, HW35512, HW35513, HW35514, HW35516, HW35517, HW35518, HW35519, HW35520, HW35521, HW35522, HW35523, HW35525, HW35526, HW35527, HW35528, HW35565, HW35567, HW35568, HW35569, HW35570, HW35593, HW35600, HW35612, HW35614, HW35615, HW35616, HW35617, HW35618, HW35645, HW35650, HW35652, HW35685, HW35725, HW35734, HW35737, HW35738, HW35740, HW35742, HW35743, HW35744, HW35745, HW35746, HW35747, HW35748, HW35751, HW35752, HW35760, HW35762, HW35765 GTIN 00888707002462, Serial Numbers: HW31586, HW31700, HW32035 GTIN 00888707002424, Serial Numbers: HW31698, HW31851 GTIN 00888707002448, Serial Numbers: HW31779, HW31780, HW32546, HW34095, HW34617, HW35398, HW35511, HW35589, HW35597 GTIN 00888707002455, Serial Numbers: HW31852, HW31856, HW32025, HW32198, HW34026, HW34637, HW35544 GTIN 00888707006019, Serial Numbers: HW31983, HW34720, HW34974, HW35376, HW35377, HW35849, HW35866, HW35869, HW35871, HW35873, HW35877, HW35878, HW35879, HW35880, HW35998, HW36000, HW36056, HW36057, HW36058, HW36059, HW36060, HW36061, HW36062, HW36063, HW36113, HW36114, HW36115, HW36116, HW36117, HW36118, HW36119, HW36120, HW36145, HW36146, HW36155, HW36156, HW36157, HW36158, HW36159, HW36167, HW36221, HW36222, HW36223, HW36350, HW36351, HW36352 GTIN 00888707006408, Serial Numbers: HW34292, HW35932, HW36083, HW36084, HW36087, HW36129, HW36130, HW36171, HW36172, HW36173, HW36212, HW36247, HW36250, HW36261, HW36263, HW36264, HW36265, HW36266, HW36348, HW36349, HW36413, HW36414, HW36415, HW36416, HW36594, HW36638 GTIN 00888707002554, Serial Numbers: HW34337, HW34362, HW34484, HW34591, HW34594, HW34625, HW34682, HW34693, HW34732, HW34833, HW34838, HW34846, HW34876, HW34884, HW34889, HW35052, HW35057, HW35061, HW35067, HW35316, HW35323, HW35359, HW35362, HW35363, HW35364, HW35458, HW35536, HW35585, HW35620, HW35622, HW35623, HW35709, HW35710, HW35728, HW35732, HW35758, HW35759, HW35764, HW35767, HW35771, HW35772, HW35775, HW35777, HW35780, HW35782 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707002141, Serial Numbers: HW34848, HW34849, HW35711 GTIN 00888707006323, Serial Numbers: HW34982, HW35031, HW35379, HW35380, HW35381, HW35382, HW35383, HW35384, HW35388, HW35389, HW35390, HW35391, HW35392, HW35621, HW35642, HW35654, HW35712, HW35722, HW35727, HW35729, HW35736, HW35755, HW35770, HW35781, HW35783, HW35977, HW36024, HW36025, HW36027, HW36028, HW36029, HW36030, HW36032, HW36033, HW36034, HW36042, HW36043, HW36044, HW36045, HW36046, HW36064, HW36065, HW36072, HW36073, HW36074, HW36075, HW36076, HW36077, HW36078, HW36079, HW36080, HW36081, HW36082, HW36123, HW36124, HW36125, HW36126, HW36127, HW36128, HW36133, HW36134, HW36135, HW36136, HW36137, HW36139, HW36140, HW36141, HW36142, HW36143, HW36144, HW36147, HW36148, HW36149, HW36150, HW36151, HW36152, HW36153, HW36187, HW36188, HW36189, HW36190, HW36191, HW36202, HW36203, HW36204, HW36206, HW36207, HW36208, HW36209, HW36210, HW36234, HW36235, HW36236, HW36237, HW36238, HW36239, HW36242, HW36244, HW36245, HW36267, HW36268, HW36271, HW36272, HW36274, HW36275, HW36284, HW36286, HW36290, HW36291, HW36292, HW36293, HW36295, HW36296, HW36297, HW36339, HW36340, HW36342, HW36343, HW36344, HW36346, HW36364, HW36366, HW36367, HW36375, HW36378, HW36379, HW36380, HW36439, HW36440, HW36441, HW36443, HW36444, HW36445, HW36446, HW36450, HW36451, HW36452, HW36453, HW36454, HW36455, HW36456, HW36520, HW36521, HW36522, HW36524, HW36528, HW36529, HW36532, HW36533, HW36534, HW36535, HW36537, HW36539, HW36548, HW36549, HW36550, HW36551, HW36552, HW36604, HW36605, HW36606, HW36607, HW36608, HW36639, HW36640, HW36641, HW36645, HW36649, HW36651, HW36661, HW36674, HW36675, HW36676, HW36687, HW36714, HW36729, HW36731, HW36732, HW36733, HW36734, HW36735, HW36737, HW36738, HW36739, HW36744, HW36908, HW36909, HW36922, HW36923, HW36925, HW36932 GTIN 00888707005951, Serial Numbers: HW35279, HW35331, HW35503, HW35524, HW35581, HW35675, HW35715, HW35720, HW35739, HW35768, HW35787, HW35788, HW35789, HW35790, HW35791, HW35792, HW35793, HW35794, HW35795, HW35796, HW35797, HW35798, HW35799, HW35821, HW35822, HW35823, HW35824, HW35825, HW35826, HW35827, HW35831, HW35833, HW35834, HW35835, HW35836, HW35837, HW35838, HW35839, HW35840, HW35841, HW35842, HW35843, HW35844, HW35845, HW35846, HW35883, HW35887, HW35888, HW35889, HW35890, HW35891, HW35892, HW35893, HW35894, HW35895, HW35896, HW35897, HW35898, HW35900, HW35905, HW35906, HW35907, HW35921, HW35925, HW35926, HW35928, HW35930, HW35933, HW35934, HW35945, HW35946, HW35947, HW35948, HW35949, HW35950, HW35951, HW35952, HW35953, HW35954, HW35955, HW35956, HW35957, HW35959, HW35960, HW35961 GTIN 00888707002264, Serial Numbers: HW35741, HW35773 GTIN 00888707006316, Serial Numbers: HW35754, HW35774, HW35865, HW35868, HW35874, HW35940, HW35958, HW35962, HW35963, HW35964, HW35965 GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35819, 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, HW35973, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997 GTIN 00888707006309, Serial Numbers: HW35876, HW35882, HW35884, HW35885, HW35886, HW35941, HW35942, HW35999 GTIN 00888707006347, Serial Numbers: HW35902, HW35903, HW35908, HW35909, HW35910, HW35911, HW35912, HW35913, HW35914, HW35915, HW35918, HW35920, HW36001, HW36002, HW36003, HW36016, HW36035, HW36036, HW36037, HW36038, HW36039, HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623 GTIN 00888707006446, Serial Numbers: HW35979, HW35980, HW35982, HW35984, HW36160, HW36161, HW36162, HW36163, HW36164, HW36278, HW36287, HW36381, HW36382, HW36383, HW36384, HW36385, HW36386, HW36387, HW36388, HW36460, HW36462, HW36464, HW36465, HW36469, HW36470, HW36471, HW36472, HW36480, HW36481, HW36482, HW36483, HW36484, HW36486, HW36487, HW36489, HW36491, HW36492, HW36494, HW36495 GTIN 00888707006392, Serial Numbers: HW35986, HW35987, HW36066, HW36085, HW36086, HW36213, HW36214, HW36215, HW36216, HW36217, HW36218, HW36219, HW36220, HW36289, HW36311, HW36417, HW36418, HW36517, HW36587, HW36588, HW36589, HW36590, HW36652, HW36656, HW36860 GTIN 00888707007290, Serial Numbers: HW36421, HW36422 GTIN 00888707006354, Serial Numbers: HW36838, HW36880 No GTIN, Serial Numbers: HW26099, HW26126, HW26330, HW26660, HW26939, HW26940, HW27099, HW27452, HW27678, HW28063, HW28199, HW28373, HW28418, HW28895, HW28973, HW29073, HW29214, HW29298, HW29318, HW29351, HW29353, HW29354, HW29359

Distribution pattern

Worldwide Distribution

device · product 3 of 5

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

Z-2057-2020

Recall number: Z-2057-2020
Initiated: April 03, 2020
Classification: Class I
Status: Ongoing
Recalling firm: Heartware, Inc.
Quantity: 85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Code information

GTIN 00888707000697, Serial numbers: HW34700, HW34703, HW34710, HW34713 GTIN 00888707005838, Serial Numbers: HW40383, HW40412, HW40413, HW40414, HW40415, HW40417, HW40418, HW40419, HW40420, HW40421, HW40422, HW40423, HW40424, HW40425, HW40426, HW40428, HW40429, HW40431, HW40465, HW40471, HW40472, HW40473, HW40474, HW40475, HW40476, HW40477, HW40478, HW40479, HW40480, HW40552, HW40553, HW40554, HW40555, HW40556, HW40557, HW40564, HW40565, HW40580, HW40599, HW40600, HW40602, HW40603, HW40604, HW40607, HW40609, HW40611, HW40612, HW40613, HW40649, HW40650, HW40651, HW40652, HW40653, HW40655, HW40656, HW40657, HW40658, HW40659, HW40660, HW40661, HW40662, HW40663, HW40664, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045

Distribution pattern

Worldwide Distribution

device · product 4 of 5

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Z-2058-2020

Recall number: Z-2058-2020
Initiated: April 03, 2020
Classification: Class I
Status: Ongoing
Recalling firm: Heartware, Inc.
Quantity: 20147 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Code information

All lots and serial numbers in distribution

Distribution pattern

Worldwide Distribution

device · product 5 of 5

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

Z-2059-2020

Recall number: Z-2059-2020
Initiated: April 03, 2020
Classification: Class I
Status: Ongoing
Recalling firm: Heartware, Inc.
Quantity: 560 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Code information

GTIN 00888707000147, All lot numbers in distribution

Distribution pattern

Worldwide Distribution