FDAFDA · Food and drugs·Recall number Z-2450-2012
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Published October 3, 2012 · Recall initiated: August 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Vascular
- Distributor
- Nationwide(US) Distribution and Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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