Recall Z-1178-2010 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| Date | Mar 22, 2010 (initiated May 6, 2009) |
| Status | Terminated |
| Reason | Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging. |
| Root cause | Labeling mix-ups |
| Action | Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902. |
| Quantity | 26 |
| Distribution | Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER Abbott Vascular-Vascular Solutions, Jan 31, 2008 |