Reported Oct 3, 2012 · Terminated
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Abbott Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
- Lot codes and dates
706 of 706 codes
U.S. Lot #: 737538737576738162738486738641739286739518739837740078740090740306740310740575740579740583740591740599740824740828740832740836742024742028742032742036742040742234742238742246742250742509742513742517742521742759742767742775742783742932742936742940742944742948742952742956743092743096743100743194743197743203743206743209743212743215743469743473743477743481743489
- Amount recalled
- 61,799 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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