Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA device recall Z-2450-2012 · posted 2012-09-25 · Terminated
Recall details
- Recalling firm
- Abbott Vascular
- 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.
- Action taken
- An "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 61,799 units
- Distribution
- Nationwide(US) Distribution and Puerto Rico.
- Date initiated
- 2012-08-20
- Date posted
- 2012-09-25
- Date terminated
- 2013-07-15
- Location
- Temecula, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARMADA 35/35LL PTA CATHETER (K111899) | Abbott Vascular | 2011-10-03 |