Recall Z-2450-2012— Abbott Vascular
Class II · Terminated
Class II FDA medical device recall by Abbott Vascular, initiated 2012-08-20, terminated 2013-07-15. It names one FDA 510(k) clearance: K111899. 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..
- Recalling firm
- Abbott Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-20
- Terminated
- 2013-07-15
- Firm location
- Temecula, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.