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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Lot Codes / Batch Numbers
Lot Number: 8121251.
Products Sold
Lot Number: 8121251.
Abbott Vascular-Cardiac Therapies dba Guidant Corporation is recalling Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufac due to Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026