Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Enforcement
- Recall Number
- Z-2450-2012
- Event ID
- 63092
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Vascular
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 3, 2012
- Initiation Date
- August 20, 2012
- Classification Date
- September 25, 2012
- Termination Date
- July 15, 2013
- Address
- 26531 Ynez Rd, N/A, Temecula, CA, 92591-4630, United States
Description
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
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.
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Nationwide(US) Distribution and Puerto Rico.
61,799 units