Recall Z-2039-2017 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Abbott Vascular
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
| Date | May 12, 2017 (initiated Mar 22, 2017) |
| Status | Terminated |
| Reason | Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. |
| Root cause | Device Design |
| Action | An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local A |
| Quantity | 449,661 units total (132,040 units in US) |
| Distribution | US and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER Abbott Vascular-Cardiac Therapies, Dec 30, 2010 |