Data Foundry

Medical device recalls 2012

Armada 35/ Armada 35 LL PTA Catheters — Class II medical device recall Z-2450-2012

Terminated recall by Abbott Vascular, reported 2012-10-03, distributed nationwide. Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that so

Recall numberZ-2450-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAbbott Vascular, Temecula, CA, United States
Recall initiated2012-08-20
Classified2012-09-25
Reported by FDA2012-10-03
Terminated2013-07-15
DistributedNationwide (US)
Quantity61,799 units
Lot numbers737538, 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 and 460 more

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2450-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.