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U.S. Department of Health and Human Services

Class 2 Device Recall Armada Catheters

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 Class 2 Device Recall Armada Catheterssee related information
Date Initiated by FirmAugust 20, 2012
Date PostedSeptember 25, 2012
Recall Status1 Terminated 3 on July 15, 2013
Recall NumberZ-2450-2012
Recall Event ID 63092
510(K)NumberK111899 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductArmada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Code Information U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 740579, 740583, 740591, 740599, 740824, 740828, 740832, 740836, 742024, 742028, 742032, 742036, 742040, 742234, 742238, 742246, 742250, 742509, 742513, 742517, 742521, 742759, 742767, 742775, 742783, 742932, 742936, 742940, 742944, 742948, 742952, 742956, 743092, 743096, 743100, 743194, 743197, 743203, 743206, 743209, 743212, 743215, 743469, 743473, 743477, 743481, 743489, 743565, 743862, 743866, 743870, 743874, 743878, 743882, 743886, 744277, 744285, 744289, 744293, 744297, 744301, 744361, 744419, 744423, 744427, 744431, 744435, 744525, 744618, 744622, 744626, 744630, 744634, 744874, 744878, 744882, 744886, 744890, 744894, 745237, 745245, 745249, 745253, 745538, 745542, 745547, 745731, 745735, 745743, 745747, 745949, 745953, 745957, 745961, 745965, 745969, 746237, 746249, 746253, 746257, 746358, 746362, 746366, 746370, 746565, 746569, 746767, 746783, 746968, 746972, 746976, 747149, 747153, 747161, 747165, 747326, 747347, 747351, 747545, 747549, 747565, 747736, 747740, 747744, 747753, 747757, 747765, 747899, 747907, 748103, 748107, 748111, 748115, 748119, 748127, 748309, 748317, 748321, 748437, 748473, 748608, 749158, 749174, 749312, 749320, 749324, 749328, 749332, 749336, 749340, 749537, 749582, 749800, 749933, 749937, 749980, 749988, 750000, 750008, 750130, 750134, 750150, 750154, 750315, 750319, 750324, 750332, 750336, 750340, 750344, 750487, 750491, 750495, 750500, 750504, 750508, 750829, 750833, 750845, 751169, 751326, 751334, 751338, 751342, 751529, 751533, 751889, 751897, 752089, 752097, 752349, 752369, 752429, 752441, 752453, 752461, 752619, 752623, 752627, 752639, 752643, 752777, 752781, 752785, 752794, 752798, 752802, 753142, 753150, 753153, 753169, 753173, 753277, 753281, 753285, 753289, 753297, 753481, 753485, 753608, 753726, 753730, 753734, 754054, 754062, 754066, 754070, 754074, 754187, 754191, 754599, 754603, 754607, 754619, 754623, 754783, 754787, 754791, 754795, 754799, 754803, 754948, 755240, 755244, 755431, 755443, 755606, 755610, 755614, 755792, 755818, 755826, 755834, 755838, 755842, 756002, 756006, 756010, 756156, 756160, 756164, 756169, 756173, 756177, 756441, 756445, 756465, 756469, 756473, 756477, 756481, 756662, 756666, 756670, 756694, 756698, 756702, 756868, 756872, 756876, 756880, 756884, 757077, 757081, 757085, 757089, 757260, 757264, 757268, 757280, 757296, 757440, 757456, 757472, 757476, 757676, 757680, 757684, 757692, 757696, 757704, 757708, 757712, 757716, 757890, 757894, 757898, 757902, 757914, 757918, 757922, 757926, 758067, 758071, 758075, 758079, 758083, 758087, 758091, 758095, 758288, 758296, 758300, 758304, 758312, 758316, 758324, 758500, 758504, 758508 ,758528, 758875, 758879, 758883, 758887, 758891, 758895, 758899, 758903, 759090, 759094, 759102, 759106, 759110, 759114, 759118, 759122, 759270, 759278, 759282, 759429, 759433, 759437, 759441, 759445, 759449, 759453, 759457, 759662, 759666, 759670, 759674, 759678, 759682, 759686, 759840, 759848, 759852, 759856, 759864, 759868, 759872, 759876, 759880, 760039, 760047, 760051, 760059, 760063, 760067, 760071, 760075, 760079, 760208, 760212, 760216, 760220, 760224, 760228, 760232, 760236, 760240, 760248, 760458, 760462, 760466, 760470, 760482, 760689, 760693, 760697, 760701, 760705, 760854, 760858, 760862, 760866, 760878, 760882, 761215, 761231, 761243, 761486, 761495, 761499, 761503, 761507, 761511, 761523, 761735, 761739, 761743, 761747, 761752, 761764, 761768, 761932, 761936, 761940, 761944, 761948, 761952, 761960, 762070, 762109, 762113, 762121, 762129, 762133, 762137, 762292, 762296, 762300, 762304, 762308, 762312, 762316, 762320, 762324, 762466, 762474, 762478, 762482, 762486, 762512, 762671, 762679, 762683, 762687, 762691, 762699, 762841, 762845, 762853, 762857, 762861, 762869, 763000, 763008, 763012, 763016, 763024, 763143, 763151, 763155, 763163, 763167, 763171, 763191, 763195, 763203, 763211, 763215, 763220, 763224, 763238, 763242, 763246, 763258, 763262, 763266, 763270, 763306, 763310, 763314, 763318, 763322, 763326, 763330, 763492, 763496, 763499, 763502, 763506, 763610, 763614, 763618, 763626, 763630, 763634, 763638, 763642, 763646, 763770, 763774, 763778, 763782, 763786, 763794, 763798, 763802, 763806, 763894, 763898, 763902, 763906, 763910, 763914, 763918, 763922, 763926, 764075, 764084, 764088, 764130, 764134, 764142, 764146, 764150, 764154, 764158, 764162, 764169, 764193, 764205, 764221, 764229, 764237, 764241, 764269, 764367, 764375, 764379, 764383, 764387, 764395, 764399, 764460, 764476, 764484, 764488, 764492, 764496, 764500, 764508, 764512, 764615, 764619, 764663, 764667, 764680, 764684, 764852, 764869, 765196, 765200, 765226, 765358, 765366, 765370, 765374, 765404, 765431, 765435, 765682, 765906, 766065, 766230, 766246, 766250, 766254, 766262, 766488, 766683, 766691, 766695, 766855, 766859, 766871, 767020, 767024, 767028, 767032, 767040, 767184, 767192, 767212, 767216, 767349, 767361, 767582, 767586, 767728, 767752, 767756, 767760, 767971, 767983, 767987, 768122, 768243, 768248, 768252, 768256, 768260, 768264, 768362, 768378, 768382, 768469, 768473, 768477, 768481, 768485, 768489, 768501, 768505, 768594, 768659, 768667, 768671, 769031, 769035, 769178, 769190, 769346, 769350, 769517, 769521, 769525, 769529, 769541, 769549, 769553, 769861, 769865, 769965, 769973, 769977, 769981, 770130, 770142, 770146, 770154, 770162, 770333, 770345, 770349, 770679, 770699, 770703, 770707, 771042, 771046, 771050, 771208, 771212, 771216, 771220, 771437, 771441, 771667, 771679, 771960, 771968, 772157, 772415, 772560, 772806, 773110, 773114, 774228, 774698.
Recalling Firm/
Manufacturer
Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall
Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
FDA Determined
Cause 2
Process design
ActionAn "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.
Quantity in Commerce61,799 units
DistributionNationwide(US) Distribution and Puerto Rico.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LIT
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