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).
This recall has been terminated (originally issued July 11, 2007).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- March 23, 2007
- Posted
- July 11, 2007
- Terminated
- March 2, 2008
- Recall Number
- Z-1050-2007
- Quantity
- 1,217
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.