Z-1050-2007

These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK...

Name: Z-1050-2007 These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK...
Creator: Boston Scientific CRM Corp
Published: 2007-03-23
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-03-23 / Terminated / root cause: supplier

FDA source

Boston Scientific CRM Corp began a recall of These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac... on 2007-03-23. The reason FDA records is "Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1050-2007
Status: Terminated
Initiated: 2007-03-23
Posted: 2007-07-11
Terminated: 2008-03-02
Recalling firm: Boston Scientific Corporation
Product: These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac resynchronization therapy defibrillator (CRT-D).
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.
Root cause tag: supplier
FDA root cause: Other
Action: An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
Quantity in commerce: 1,217
Distribution: Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
Product codes and lots: Model H230, serial numbers: 100013, 100018, 100020, 100025, 200003, 200005, 200007, 200010, 200012, 200013, 200014, 200015, 200016, 200017, 200019, 200020, 200021, 200024, 200025, 200026, 200027, 200029, 200030, 200031, 200053, 200054, 200055, 200056, 200057, 200058, 200059, 200060, 200061, 200062, 200063, 200064, 200065, 200066, 200067, 200068, 200070, 200072, 200073, 200074, 200075, 200077, 200079, 200080, 200081, 200082, 200083, 200084, 200085, 200086, 200087, 200088, 200089, 200090, 200091, 200092, 200094, 200095, 200096, 200097, 200098, 200099, 200100, 200101, 200102, 200103, 200104, 200106, 200107, 200108, 200110, 200112, 200113, 200114, 200115, 200116, 200117, 200118, 200119, 200120, 200121, 200122, 200123, 200126, 200127, 200128, 200129, 200130, 200131, 200132, 200133, 200134, 200135, 200136, 200137, 200138, 200139, 200140, 200141, 200143, 200145, 200146, 200147, 200148, 200149, 200150, 200151, 200152, 200156, 200157, 200158, 200159, 200160, 200161, 200163, 200168, 200169, 200171, 200172, 200173, 200174, 200175, 200176, 200177, 200178, 200179, 200180, 200181, 200184, 200185, 200186, 200187, 200188, 200189, 200190, 200192, 200193, 200194, 200196, 200197, 200198, 200199, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200211, 200212, 200213, 200215, 200217, 200218, 200219, 200220, 200221, 200222, 200223, 200224, 200225, 200226, 200227, 200228, 200229, 200230, 200231, 200232, 200233, 200235, 200236, 200238, 200239, 200241, 200242, 200243, 200244, 200245, 200246, 200248, 200250, 200252, 200253, 200254, 200255, 200257, 200258, 200259, 200260, 200261, 200262, 200264, 200265, 200268, 200269, 200270, 200271, 200272, 200273, 200274, 200275, 200277, 200278, 200279, 200280, 200281, 200282, 200283, 200284, 200285, 200286, 200287, 200288, 200289, 200290, 200291, 200293, 200294, 200295, 200296, 200298, 200299, 200300, 200302, 200303, 200304, 200305, 200306, 200307, 200309, 200310, 200311, 200312, 200313, 200314, 200315, 200316, 200317, 200318, 200320, 200321, 200322, 200323, 200324, 200325, 200326, 200327, 200330, 200331, 200332, 200333, 200334, 200335, 200336, 200337, 200339, 200340, 200341, 200346, 200347, 200351, 200352, 200356, 200357, 200358, 200362, 200363, 200364, 200366, 200367, 200368, 200369, 200370, 200379, 200387, 200388, 200389, 200390, 200391, 200393, 200394, 200396, 200397, 200398, 200400, 200401, 200402, 200403, 200404, 200407, 200410, 200411, 200412, 200414, 200418, 200419, 200420, 200421, 200422, 200423, 200429, 200431, 200434, 200439, 200440, 200441, 200461, 200463, 200468, 200485, 200507, 200517, 200518, 200519, 200520, 200521, 200526, 200527, 200530, 200531, 200532, 200533, 200534, 200535, 200536, 200572, 200576, 200578, 200579, 200580, 200584, 200588, 200594, 200595, 200596, 200597, 200598, 200599, 200603, 200604, 200605, 200606, 200607, 200608, 200609, 200610, 200611, 200612, 200613, 200614, 200615, 200616, 200617, 200619, 200620, 200622, 200623, 200624, 200625, 200626, 200628, 200629, 200630, 200632, 200633, 200634, 200635, 200637, 200638, 200639, 200641, 200642, 200643, 200644, 200645, 200646, 200647, 200648, 200649, 200650, 200651, 200652, 200653, 200654, 200655, 200656, 200657, 200658, 200659, 200660, 200661, 200663, 200664, 200665, 200666, 200667, 200668, 200669, 200670, 200671, 200672, 200673, 200674, 200675, 200676, 200677, 200678, 200679, 200680, 200681, 200682, 200683, 200684, 200685, 200686, 200688, 200689, 200690, 200691, 200692, 200695, 200696, 200701, 200716, 200717, 200720, 200724, 200725, 200726, 200728, 200729, 200730, 200731, 200732, 200733, 200734, 200735, 200736, 200737, 200738, 200739, 200741, 200742, 200743, 200745, 200746, 200747, 200748, 200749, 200750, 200751, 200752, 200756, 200758, 200759, 200760, 200762, 200764, 200773, 200774, 200776, 200777, 200788, 200835, 200845, 200847, 200848, 200906, 200948, 200951, 200953, 200954, 200956, 200960, 200961, 200962, 200963, 200965, 200969, 200970, 200971, 200973, 200983, 201147, 201239, 201240, 201245, 201301, 201318. Model H235, serial numbers: 100018, 100021, 100022, 100024, 100027, 100028, 100029, 100031, 100033, 100034, 100035, 100036, 100042, 100047, 100051, 100071, 650027, 650028, 650030, 650033, 650036, 650037, 650038, 650040, 650041, 650043, 650044, 650045, 650047, 650049, 650050, 650051, 650052, 650053, 650054, 650055, 650056, 650057, 650058, 650059, 650060, 650061, 650062, 650065, 650066, 650067, 650069, 650070, 650071, 650072, 650074, 650075, 650076, 650077, 650078, 650079, 650080, 650081, 650082, 650083, 650084, 650085, 650086, 650087, 650088, 650089, 650090, 650091, 650092, 650093, 650094, 650095, 650096, 650098, 650099, 650101, 650102, 650103, 650104, 650105, 650106, 650107, 650108, 650109, 650110, 650111, 650112, 650113, 650114, 650115, 650116, 650117, 650118, 650119, 650120, 650123, 650124, 650125, 650126, 650137, 650139, 650140, 650141, 650142, 650144, 650146, 650147, 650148, 650149, 650150, 650151, 650152, 650153, 650154, 650155, 650156, 650157, 650158, 650160, 650161, 650163, 650165, 650166, 650167, 650168, 650170, 650171, 650172, 650174, 650175, 650176, 650177, 650178, 650179, 650180, 650181, 650182, 650183, 650184, 650185, 650188, 650189, 650190, 650191, 650192, 650195, 650196, 650197, 650198, 650199, 650200, 650201, 650202, 650203, 650204, 650208, 650209, 650211, 650212, 650216, 650217, 650222, 650227, 650229, 650230, 650232, 650234, 650235, 650236, 650237, 650238, 650239, 650241, 650242, 650246, 650249, 650252, 650253, 650254, 650255, 650256, 650257, 650262, 650263, 650264, 650265, 650266, 650267, 650268, 650269, 650272, 650273, 650274, 650276, 650278, 650279, 650280, 650282, 650283, 650286, 650287, 650288, 650289, 650290, 650292, 650293, 650295, 650304, 650306, 650307, 650308, 650309, 650310, 650311, 650313, 650315, 650316, 650318, 650319, 650321, 650322, 650324, 650325, 650326, 650327, 650328, 650329, 650330, 650331, 650332, 650333, 650334, 650346, 650348, 650349, 650350, 650351, 650352, 650353, 650354, 650355, 650356, 650357, 650358, 650359, 650360, 650361, 650362, 650363, 650364, 650365, 650368, 650369, 650370, 650371, 650372, 650373, 650374, 650375, 650376, 650378, 650379, 650380, 650381, 650382, 650383, 650384, 650385, 650386, 650388, 650389, 650390, 650391, 650392, 650393, 650394, 650396, 650397, 650398, 650400, 650401, 650402, 650403, 650405, 650406, 650407, 650408, 650410, 650411, 650412, 650413, 650414, 650415, 650416, 650418, 650419, 650420, 650421, 650423, 650424, 650427, 650428, 650429, 650432, 650433, 650435, 650437, 650438, 650439, 650441, 650448, 650449, 650476, 650478, 650486, 650488, 650493, 650494, 650495, 650496, 650497, 650498, 650499, 650500, 650501, 650502, 650503, 650511, 650515, 650519, 650521, 650522, 650523, 650526, 650527, 650533, 650534, 650535, 650538, 650540, 650541, 650542, 650543, 650557, 650558, 650559, 650565, 650567, 650570, 650571, 650572, 650573, 650577, 650581, 650582, 650583, 650586, 650587, 650589, 650593, 650601, 650602, 650603, 650604, 650605, 650606, 650608, 650609, 650611, 650612, 650613, 650614, 650615, 650616, 650621, 650622, 650623, 650624, 650625, 650626, 650627, 650628, 650629, 650630, 650631, 650632, 650633, 650634, 650635, 650636, 650637, 650638, 650639, 650641, 650643, 650644, 650645, 650646, 650648, 650649, 650651, 650653, 650654, 650655, 650656, 650657, 650658, 650659, 650660, 650661, 650663, 650664, 650665, 650666, 650667, 650668, 650669, 650670, 650671, 650672, 650673, 650676, 650679, 650680, 650684, 650685, 650686, 650687, 650690, 650692, 650696, 650697, 650698, 650700, 650719, 650722, 650754, 650755, 650757, 650760, 650761, 650772, 650774, 650778, 650792, 650796, 650798, 650810, 650852, 650854, 650855, 650857, 650858, 650859, 650861, 650862, 650864, 650865, 650866, 650877, 650878, 650879, 650880, 650881, 650882, 650883, 650884, 650885, 650886, 651007, 651009, 651011, 651087. Model H239, serial numbers: 650006, 650007, 650009, 650010, 650011, 650012, 650013, 650014, 650015, 650016, 650017, 650018, 650019, 650020, 650021, 650022, 650023, 650024, 650025, 650026, 650027, 650028, 650029, 650030, 650031, 650033, 650035, 650037, 650038, 650039, 650040, 650041, 650042, 650043, 650044, 650045, 650046, 650047, 650048, 650050, 650051, 650052, 650053, 650054, 650055, 650056, 650057, 650058, 650059, 650060, 650061, 650062, 650063, 650064, 650065, 650067, 650076, 650077, 650078, 650079, 650080, 650081, 650082, 650083, 650084, 650085, 650086, 650087, 650089, 650090, 650091, 650092, 650093, 650096, 650097, 650098, 650099, 650100, 650101, 650102, 650103, 650104, 650105, 650106, 650107, 650109, 650110, 650111, 650112, 650113, 650114, 650116, 650118, 650120, 650121, 650122, 650123, 650124, 650125, 650126, 650127, 650128, 650130, 650132, 650133, 650134, 650135, 650136, 650137, 650138, 650140, 650141, 650142, 650143, 650144, 650147, 650148, 650149, 650150, 650152, 650153, 650154, 650155, 650156, 650157, 650158, 650159, 650160, 650162, 650163, 650164, 650165, 650167, 650168, 650170, 650171, 650173, 650174, 650175, 650176, 650177, 650178, 650179, 650180, 650181, 650182, 650186, 650188, 650190, 650193, 650194, 650195, 650196, 650197, 650198, 650199, 650201, 650202, 650203, 650204, 650205, 650208, 650211, 650212, 650213, 650215, 650216, 650218, 650219, 650220, 650221, 650222, 650223, 650224, 650225, 650226, 650227, 650228, 650229, 650230, 650231, 650232, 650234, 650236, 650237, 650242, 650245, 650250, 650255, 650258, 650259, 650260, 650261, 650262, 650273, 650275, 650278, 650280, 650281, 650285, 650287, 650288, 650304, 650307, 650308, 650309, 650312, 650313, 650314, 650319, 650320, 650321, 650322, 650323, 650324, 650325, 650326, 650327, 650328, 650329, 650332, 650339, 650340, 650341, 650342, 650343, 650344, 650345, 650346, 650347, 650348, 650349, 650350, 650351, 650352, 650353, 650354, 650355, 650356, 650357, 650358, 650359, 650360, 650361, 650362, 650363, 650384, 650600.

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)