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U.S. Department of Health and Human Services

Class 2 Device Recall CONTAK RENEWAL 3 RF

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 Class 2 Device Recall CONTAK RENEWAL 3 RF see related information
Date Posted July 11, 2007
Recall Status1 Terminated on March 02, 2008
Recall Number Z-1049-2007
Recall Event ID 37769
PMA Number P010012 
Product Classification implantable defibrillator - Product Code NIK
Product CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
Code Information 947, 200948, 200949, 200950, 200951, 200953, 200954, 200955, 200958, 200959, 200962, 200965, 200966, 200969, 200972, 200973, 200975, 200976, 200977, 200978, 200979, 200981, 200982, 200983, 200984, 200985, 200988, 200989, 200990, 200991, 200992, 200993, 200994, 200997, 200998, 201000, 201002, 201003, 201004, 201005, 201006, 201008, 201009, 201010, 201011, 201012, 201013, 201015, 201016, 201017, 201020, 201021, 201023, 201025, 201026, 201029, 201030, 201032, 201033, 201036, 201040, 201041, 201042, 201043, 201045, 201046, 201048, 201051, 201052, 201053, 201055, 201056, 201057, 201058, 201059, 201060, 201062, 201063, 201064, 201065, 201066, 201067, 201068, 201070, 201071, 201072, 201073, 201074, 201075, 201076, 201078, 201080, 201081, 201083, 201084, 201085, 201086, 201088, 201090, 201091, 201092, 201093, 201094, 201095, 201096, 201098, 201099, 201100, 201104, 201105, 201106, 201107, 201108, 201109, 201110, 201111, 201112, 201113, 201114, 201115, 201118, 201119, 201121, 201122, 201124, 201125, 201126, 201127, 201128, 201129, 201130, 201132, 201134, 201136, 201137, 201138, 201140, 201141, 201142, 201145, 201146, 201147, 201148, 201152, 201153, 201154, 201155, 201158, 201159, 201160, 201161, 201162, 201164, 201165, 201166, 201167, 201168, 201169, 201170, 201172, 201173, 201174, 201175, 201176, 201177, 201178, 201181, 201182, 201183, 201184, 201185, 201187, 201188, 201189, 201192, 201193, 201194, 201195, 201196, 201197, 201198, 201200, 201201, 201202, 201203, 201204, 201205, 201207, 201208, 201210, 201211, 201212, 201213, 201214, 201217, 201218, 201220, 201223, 201224, 201225, 201227, 201229, 201230, 201231, 201233, 201234, 201235, 201238, 201239, 201240, 201242, 201243, 201244, 201245, 201247, 201248, 201249, 201250, 201251, 201253, 201254, 201255, 201256, 201257, 201259, 201261, 201263, 201264, 201265, 201266, 201267, 201268, 201269, 201271, 201272, 201273, 201274, 201278, 201279, 201280, 201281, 201282, 201283, 201284, 201285, 201286, 201287, 201288, 201289, 201290, 201291, 201292, 201296, 201297, 201298, 201299, 201301, 201302, 201303, 201304, 201305, 201306, 201307, 201308, 201309, 201310, 201311, 201312, 201313, 201314, 201315, 201317, 201318, 201319, 201320, 201321, 201322, 201323, 201324, 201325, 201326, 201327, 201328, 201329, 201330, 201332, 201333, 201334, 201335, 201336, 201337, 201338, 201339, 201340, 201342, 201343, 201344, 201345, 201346, 201348, 201349, 201353, 201354, 201355, 201356, 201357, 201358, 201359, 201360, 201362, 201364, 201365, 201366, 201367, 201368, 201370, 201371, 201373, 201374, 201376, 201377, 201378, 201379, 201381, 201382, 201383, 201384, 201385, 201386, 201387, 201389, 201390, 201391, 201393, 201394, 201395, 201397, 201398, 201399, 201400, 201401, 201403, 201406, 201407, 201408, 201409, 201410, 201417, 201418, 201419, 201420, 201421, 201422, 201424, 201425, 201426, 201427, 201428, 201430, 201431, 201432, 201433, 201434, 201435, 201436, 201437, 201438, 201439, 201440, 201441, 201442, 201444, 201445, 201446, 201447, 201449, 201450, 201452, 201455, 201458, 201459, 201460, 201461, 201462, 201468, 201469, 201470, 201472, 201473, 201474, 201475, 201477, 201478, 201479, 201480, 201481, 201482, 201483, 201487, 201488, 201489, 201490, 201491, 201492, 201494, 201495, 201496, 201497, 201498, 201502, 201504, 201505, 201506, 201507, 201510, 201511, 201513, 201523, 201525, 201527, 201528, 201529, 201530, 201531, 201533, 201537, 201541, 201542, 201544, 201545, 201546, 201547, 201548, 201549, 201552, 201553, 201554, 201555, 201557, 201558, 201559, 201560, 201561, 201562, 201567, 201568, 201569, 201572, 201573, 201575, 201576, 201577, 201578, 201580, 201581, 201582, 201583, 201585, 201587, 201588, 201589, 201590, 201591, 201592, 201593, 201594, 201595, 201596, 201597, 201598, 201601, 201603, 201605, 201607, 201609, 201610, 201612, 201614, 201615, 201616, 201617, 201618, 201619, 201621, 201623, 201624, 201625, 201626, 201628, 201630, 201631, 201633, 201634, 201635, 201636, 201638, 201639, 201640, 201641, 201643, 201
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer 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.
FDA Determined
Cause 2
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 7,315
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Original Applicant = Boston Scientific Corp.
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