FDA Device recall Z-2450-2012

Armada 35/ Armada 35 LL PTA Catheters

FDA Device
Class II
terminated
Published 2012-10-03

On 2012-10-03 the FDA classified a Class II recall of Armada 35/ Armada 35 LL PTA Catheters by Abbott Vascular, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2450-2012
Classification	Class II
Status	terminated
Initiated	2012-08-20
Published	2012-10-03
Last updated	2026-09-13 11:53 UTC
Company	Abbott Vascular
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 74… 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, 74

code_info

U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 74…

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, 74

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2450-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.