Abbott Vascular: Medical Device Recall in 2012 - (Recall #: Z-2450-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.
Product Description:

Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

Product Classification:

Class II

Date Initiated: August 20, 2012
Date Posted: October 3, 2012
Recall Number: Z-2450-2012
Event ID: 63092
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.

Status: Terminated
Product Quantity: 61,799 units
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.

Distribution Pattern:

Nationwide(US) Distribution and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated