Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Reported: October 3, 2012 Initiated: August 20, 2012 #Z-2450-2012
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.
Details
- Recalling Firm
- Abbott Vascular
- Units Affected
- 61,799 units
- Distribution
- Nationwide(US) Distribution and Puerto Rico.
- Location
- Temecula, CA
Frequently Asked Questions
What product was recalled? ▼
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.. Recalled by Abbott Vascular. Units affected: 61,799 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2450-2012.
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