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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76978

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

Open FDA event record

Event summary

Timeline bucket
March 30, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Thoratec Corporation

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

3 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 3

HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

Z-2051-2017
Recall number
Z-2051-2017
Initiated
March 30, 2017
Classification
Class I
Status
Terminated
Recalling firm
Thoratec Corporation
Quantity
24,077 active units in US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

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

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

Code information

All Serial numbers.

Distribution pattern

Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.

device · product 2 of 3

HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

Z-2052-2017
Recall number
Z-2052-2017
Initiated
March 30, 2017
Classification
Class I
Status
Terminated
Recalling firm
Thoratec Corporation
Quantity
24,077 active units in US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

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

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

Code information

Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.

Distribution pattern

Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.

device · product 3 of 3

HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

Z-2053-2017
Recall number
Z-2053-2017
Initiated
March 30, 2017
Classification
Class I
Status
Terminated
Recalling firm
Thoratec Corporation
Quantity
24,077 active units in US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

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

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

Code information

Serial Numbers PC-10255-B, PC-10329-B, PC-10357-B, PC-10476-B, PC-10478-B, PC-10486-B, PC-10518-B, PC-10519-B, PC-10524-B, PC-10525-B, PC-10538-B, PC-10540-B, PC-10544-B, PC-10626-B, PC-10629-B, PC-10973-C, PC-10976-C, PC-10977-C, PC-10986-C, PC-10988-C, PC-11017-C, PC-11018-C, PC-11019-C, PC-11027-C, PC-11041-C, PC-11044-C, PC-11050-C, PC-11055-C, PC-11056-C, PC-11063-C, PC-11068-C, PC-11073-C, PC-11077-C, PC-11082-C, PC-11083-C, PC-11085-C, PC-11086-C, PC-11090-C, PC-11104-C, PC-11105-C, PC-11106-C, PC-11136-C, PC-11142-C, PC-11150-C, PC-11151-C, PC-11152-C, PC-11156-C, PC-11163-C, PC-11164-C, PC-11168-C, PC-11200-C, PC-11209-C, PC-11228-C, PC-11231-C, PC-11233-C, PC-11234-C, PC-11236-C, PC-11237-C, PC-11239-C, PC-11240-C, PC-11246-C, PC-11248-C, PC-11249-C, PC-11251-C, PC-11253-C, PC-11255, PC-11256-C, PC-11258, PC-11261-C, PC-11262-C, PC-11263-C, PC-11264-C, PC-11265-C, PC-11268-C, PC-11270-C, PC-11272-C, PC-11273-C, PC-11275-C, PC-11276-C, PC-11278-C, PC-11279-C, PC-11282-C, PC-11283-C, PC-11340-C, PC-11343-C, PC-11349-C, PC-11351-C, PC-11352-C, PC-11353-C, PC-11357-C, PC-11361-C, PC-11373-C, PC-11378-C, PC-11379-C, PC-11380-C, PC-11382-C, PC-11389-C, PC-11390-C, PC-11391-C, PC-11392-C, PC-11393-C, PC-11394-C, PC-11396-C, PC-11397-C, PC-11398-C, PC-11404-C, PC-11414-C, PC-11417-C, PC-11419-C, PC-11422-C, PC-11428-C, PC-11432-C, PC-11436-C, PC-11437-C, PC-11439-C, PC-11443-C, PC-11455-C, PC-11456-C, PC-11457-C, PC-11459-C, PC-11468-C, PC-11469-C, PC-11474-C, PC-11476-C, PC-11477-C, PC-11481-C, PC-11489-C, PC-11495-C, PC-11497-C, PC-11499-C, PC-11500-C, PC-11501-C, PC-11502-C, PC-11506-C, PC-11507-C, PC-11508-C, PC-11509-C, PC-11510-C, PC-11511-C, PC-11518-C, PC-11519-C, PC-11520-C, PC-11532-C, PC-11536-C, PC-11541-C, PC-11542-C, PC-11547-C, PC-11551-C, PC-11552-C, PC-11553-C, PC-11554-C, PC-11559-C, PC-11560-C, PC-11572-C, PC-11576-C, PC-11579-C, PC-11583-C, PC-11596-C, PC-11597-C, PC-11598-C, PC-11603-C, PC-11607-C, PC-11614-C, PC-11632-C, PC-11637-C, PC-11638-C, PC-11642-C, PC-11656-C, PC-11673-C, PC-11690-C, PC-11693-C, PC-11694-C, PC-11695-C, PC-11701-C, PC-11704-C, PC-11706-C, PC-11707-C, PC-11714-C, PC-11716-C, PC-11717-C, PC-11723-C, PC-11724-C, PC-11727-C, PC-11729-C, PC-11734-C, PC-11736-C, PC-11739-C, PC-11740-C, PC-11741-C, PC-11744-C, PC-11745-C, PC-11746-C, PC-11747-C, PC-11749-C, PC-11771-C, PC-11773-C, PC-11775-C, PC-11776-C, PC-11777-C, PC-11780-C, PC-11790-C, PC-11793-C, PC-11794-C, PC-11796-C, PC-11797-C, PC-11798-C, PC-11801-C, PC-11803-C, PC-11804-C, PC-11810-C, PC-11812-C, PC-11816-C, PC-11819-C, PC-11842-C, PC-11869-C, PC-11886-C, PC-11888-C, PC-11889-C, PC-11905-C, PC-11907-C, PC-11909-C, PC-11910-C, PC-11913-C, PC-11915-C, PC-11918-C, PC-11922-C, PC-11923-C, PC-11927-C, PC-11928-C, PC-11929-C, PC-11930-C, PC-11931-C, PC-11939-C, PC-11940-C, PC-11988, PC-11993, PC-11997, PC-11998, PC-12002, PC-12003, PC-12004, PC-12005, PC-12006, PC-12009, PC-12017, PC-12018, PC-12019, PC-12020, PC-12021, PC-12029, PC-12034, PC-12036, PC-12038, PC-12040, PC-12041, PC-12047, PC-12049, PC-12053, PC-12054, PC-12063, PC-12067, PC-12068, PC-12076, PC-12077-D, PC-12078, PC-12081, PC-12083, PC-12087, PC-12091, PC-12092, PC-12093, PC-12096, PC-12098, PC-12101, PC-12108, PC-12111, PC-12113, PC-12115, PC-12118, PC-12121, PC-12123, PC-12131, PC-12136, PC-12145, PC-12148, PC-12154, PC-12155, PC-12158, PC-12159-D, PC-12160, PC-12165, PC-12166, PC-12168, PC-12169, PC-12171, PC-12175, PC-12176, PC-12177, PC-12181, PC-12183, PC-12184, PC-12185, PC-12187, PC-12190, PC-12203, PC-12207, PC-12209, PC-12211, PC-12216, PC-12218, PC-12219, PC-12221, PC-12222, PC-12227, PC-12229, PC-12230, PC-12231, PC-12232, PC-12235, PC-12237, PC-12239, PC-12241, PC-12242, PC-12243, PC-12253, PC-12256, PC-12258, PC-12265, PC-12266, PC-12269, PC-12270, PC-12272, PC-12273, PC-12274, PC-12276, PC-12283-E, PC-12296-E, PC-12304, PC-12305, PC-12306, PC-12307, PC-12308, PC-12310, PC-12312-E, PC-12313-E, PC-12335, PC-12339, PC-12340, PC-12341, PC-12343, PC-12344, PC-12349, PC-12351, PC-12359, PC-12364, PC-12365, PC-12371, PC-12373-E, PC-12375-E, PC-12379, PC-12380, PC-12381, PC-12383, PC-12384, PC-12386, PC-12387, PC-12390, PC-12392, PC-12393, PC-12395, PC-12396, PC-12399, PC-12405-E, PC-12407, PC-12408, PC-12411, PC-12414, PC-12415, PC-12425, PC-12427, PC-12428-D, PC-12430, PC-12433, PC-12434, PC-12436, PC-12437, PC-12439, PC-12445, PC-12453, PC-12462-E, PC-12468-D, PC-12469, PC-12471, PC-12472, PC-12476, PC-12480, PC-12487, PC-12488, PC-12490, PC-12495, PC-12497, PC-12501, PC-12503, PC-12505, PC-12507, PC-12512, PC-12513, PC-12518, PC-12531, PC-12533, PC-12538, PC-12539, PC-12541, PC-12543-D, PC-12546, PC-12547, PC-12549, PC-12550, PC-12554, PC-12555, PC-12556, PC-12559, PC-12568, PC-12570, PC-12571, PC-12572, PC-12577, PC-12579, PC-12580, PC-12581, PC-12583, PC-12586, PC-12596, PC-12597, PC-12598, PC-12602, PC-12605, PC-12606, PC-12607, PC-12609, PC-12614, PC-12615, PC-12616, PC-12629, PC-12632-E, PC-12633-E, PC-12640-E, PC-12653, PC-12654, PC-12655, PC-12656, PC-12659, PC-12662, PC-12667, PC-12670, PC-12682, PC-12683, PC-12684, PC-12685, PC-12686, PC-12687, PC-12695, PC-12697, PC-12698, PC-12701, PC-12705, PC-12709, PC-12712, PC-12716, PC-12719, PC-12721, PC-12724, PC-12725, PC-12726, PC-12729, PC-12730, PC-12732, PC-12734, PC-12737, PC-12741, PC-12750, PC-12751, PC-12760-E, PC-12764, PC-12765, PC-12767, PC-12769, PC-12770, PC-12771, PC-12776-E, PC-12778, PC-12779, PC-12784, PC-12786-E, PC-12787, PC-12789, PC-12791, PC-12795, PC-12797, PC-12798, PC-12800, PC-12801, PC-12802, PC-12804, PC-12809, PC-12818, PC-12819-E, PC-12821, PC-12822, PC-12824, PC-12826, PC-12827, PC-12830, PC-12831, PC-12833, PC-12834, PC-12838, PC-12839, PC-12840, PC-12841, PC-12842, PC-12844, PC-12848, PC-12852, PC-12853, PC-12856, PC-12857, PC-12861, PC-12865, PC-12866, PC-12868, PC-12873, PC-12875, PC-12880, PC-12883, PC-12884, PC-12886, PC-12889-E, PC-12890, PC-12894, PC-12895, PC-12897, PC-12898, PC-12901, PC-12905-E, PC-12908, PC-12914, PC-12918, PC-12920, PC-12925, PC-12927, PC-12932, PC-12933, PC-12936, PC-12937, PC-12938, PC-12941, PC-12942, PC-12943, PC-12945-E, PC-12946-E, PC-12947-E, PC-12950, PC-12952, PC-12954, PC-12956, PC-12957, PC-12958, PC-12959, PC-12960, PC-12962, PC-12963, PC-12966, PC-12968, PC-12974-E, PC-12976, PC-12994, PC-13002, PC-13004, PC-13006, PC-13008-E, PC-13011, PC-13013-E, PC-13016, PC-13022, PC-13024, PC-13055, PC-13056, PC-13058, PC-13062, PC-13064, PC-13065, PC-13066, PC-13067, PC-13068, PC-13069, PC-13072, PC-13077, PC-13078, PC-13081, PC-13082, PC-13083, PC-13085, PC-13086, PC-13087, PC-13093, PC-13096, PC-13097, PC-13104, PC-13105, PC-13107, PC-13108, PC-13112, PC-13114, PC-13118, PC-13122, PC-13123, PC-13125, PC-13126, PC-13127, PC-13129, PC-13131, PC-13132, PC-13139, PC-13140, PC-13141, PC-13143, PC-13146, PC-13151, PC-13152, PC-13160, PC-13165, PC-13166, PC-13167, PC-13174, PC-13175, PC-13176, PC-13177, PC-13184, PC-13187, PC-13189, PC-13190, PC-13192-E, PC-13204, PC-13205, PC-13206, PC-13209, PC-13210, PC-13212, PC-13213, PC-13214, PC-13221, PC-13222, PC-13223, PC-13234, PC-13235, PC-13241, PC-13242, PC-13243, PC-13246, PC-13247, PC-13250, PC-13252-E, PC-13253-E, PC-13263, PC-13264, PC-13265, PC-13266, PC-13269, PC-13273, PC-13274, PC-13277, PC-13279, PC-13282, PC-13289, PC-13290, PC-13292, PC-13296, PC-13297, PC-13299, PC-13300, PC-13302, PC-13304, PC-13306, PC-13307, PC-13310, PC-13313, PC-13320, PC-13325, PC-13332, PC-13334, PC-13335, PC-13339, PC-13353, PC-13355, PC-13356, PC-13362, PC-13365-D, PC-13367, PC-13368, PC-13369, PC-13371, PC-13376, PC-13377, PC-13379, PC-13385, PC-13386, PC-13388, PC-13389-D, PC-13392, PC-13393, PC-13399, PC-13402, PC-13403, PC-13404, PC-13405, PC-13407, PC-13415, PC-13417, PC-13419, PC-13426, PC-13429, PC-13430, PC-13434, PC-13435, PC-13438, PC-13439, PC-13440-D, PC-13442-D, PC-13444, PC-13445, PC-13446, PC-13447, PC-13448, PC-13449-E, PC-13450, PC-13453, PC-13456, PC-13457, PC-13459, PC-13460, PC-13461, PC-13463, PC-13472, PC-13478, PC-13485, PC-13492-E, PC-13505, PC-13536, PC-13537, PC-13547-E, PC-13549-E, PC-13550-E, PC-13560-E, PC-13564, PC-13566, PC-13567, PC-13568, PC-13569, PC-13570, PC-13571, PC-13575, PC-13578, PC-13580, PC-13594-E, PC-13601-E, PC-13608, PC-13618, PC-13630, PC-13635-E, PC-13638, PC-13646, PC-13647, PC-13649, PC-13651, PC-13654, PC-13655, PC-13657-E, PC-13662-E, PC-13666, PC-13667, PC-13670, PC-13678, PC-13679, PC-13693-E, PC-13701, PC-13703-E, PC-13706, PC-13707-E, PC-13711, PC-13725, PC-13738, PC-13739, PC-13745, PC-13747-E, PC-13748, PC-13751, PC-13753, PC-13754, PC-13757, PC-13758, PC-13762, PC-13765, PC-13766, PC-13774, PC-13778, PC-13780, PC-13782, PC-13783, PC-13785, PC-13787, PC-13793-E, PC-13797, PC-13799-E, PC-13801, PC-13802-E, PC-13804-E, PC-13814, PC-13818, PC-13819, PC-13822, PC-13824, PC-13825, PC-13828, PC-13829, PC-13834, PC-13839-E, PC-13841-E, PC-13843, PC-13847-E, PC-13857-E, PC-13858, PC-13862-E, PC-13863, PC-13867, PC-13868, PC-13869, PC-13872, PC-13874, PC-13875, PC-13876, PC-13877-E, PC-13878, PC-13884, PC-13885, PC-13886, PC-13888, PC-13892-E, PC-13894, PC-13895, PC-13897, PC-13901, PC-13902, PC-13907, PC-13911, PC-13913, PC-13914, PC-13915, PC-13916, PC-13918, PC-13919, PC-13920, PC-13925, PC-13927, PC-13928, PC-13932-E, PC-13933, PC-13934, PC-13935, PC-13936, PC-13939, PC-13941, PC-13942, PC-13946, PC-13949, PC-13953, PC-13954, PC-13956, PC-13957, PC-13960, PC-13974-E, PC-13976, PC-13984, PC-13986, PC-13987, PC-13988, PC-13991, PC-13992, PC-13993-E, PC-13994-E, PC-13999, PC-14003, PC-14007, PC-14011, PC-14012, PC-14013, PC-14018, PC-14024, PC-14025, PC-14026, PC-14029, PC-14035, PC-14043, PC-14044, PC-14052, PC-14055, PC-14056, PC-14057, PC-14061, PC-14070, PC-14071, PC-14072, PC-14076, PC-14078, PC-14079, PC-14080, PC-14083, PC-14084, PC-14089, PC-14092, PC-14095, PC-14102, PC-14108, PC-14110, PC-14111, PC-14113-E, PC-14114, PC-14125, PC-14126, PC-14127, PC-14130, PC-14131, PC-14135, PC-14136, 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PC-25025, PC-25027, PC-25029, PC-25030, PC-25031, PC-25033, PC-25034, PC-25036, PC-25040, PC-25043, PC-25044, PC-25049, PC-25051, PC-25054, PC-25058, PC-25060, PC-25062, PC-25064, PC-25066, PC-25068, PC-25071, PC-25072, PC-25075, PC-25076, PC-25077, PC-25078, PC-25082, PC-25084, PC-25086, PC-25088, PC-25091, PC-25093, PC-25095, PC-25096, PC-25099, PC-25100, PC-25105, PC-25106, PC-25113, PC-25117, PC-25118, PC-25119, PC-25121, PC-25122, PC-25126, PC-25128, PC-25131, PC-25138, PC-25141, PC-25144, PC-25145, PC-25153, PC-25156, PC-25157, PC-25160, PC-25161, PC-25164, PC-25166, PC-25168, PC-25178, PC-25189, PC-25191, PC-25194, PC-25195, PC-25196, PC-25199, PC-25200, PC-25203, PC-25204, PC-25206, PC-25211, PC-25215-K, PC-25242-K, PC-25257

Distribution pattern

Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.