Devices

Contak Renewal 4 RF

Fabricante

Guidant Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

5 dispositivos con un nombre similar

Más información acerca de la data acá

the Contak Renewal 4 RF and 4 RF HE Defibrillators
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Active implantable medical devices
  • Manufacturer
    Boston Scientific
Contak Renewal 4 RF HE
  • Modelo / Serial
  • Descripción del producto
    AIMD: Dual-chamber implantable defibrillator<br>Single-chamber implantable defibrillator
  • Manufacturer
    Boston Scientific GmbH
Contak Renewal 4 RF CRT-D- Systeme,
  • Modelo / Serial
    H230 und H235
  • Descripción del producto
    AIMD: Defibrillator, implantable, automatic, dual-chamber
  • Manufacturer
    Guidant GmbH & Co.
Contak Renewal 4 RF HE CRT-D-Systeme
  • Modelo / Serial
    H239
  • Descripción del producto
    AIMD: Defibrillator, implantable, automatic, dual-chamber
  • Manufacturer
    Guidant GmbH & Co.
Device Recall CONTAK RENEWAL 4 RF
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    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).
  • Manufacturer
    Boston Scientific CRM Corp