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U.S. Department of Health and Human Services

Class 2 Device Recall Viatrac 14 Plus Peripheral Dilatation Catheter

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  Class 2 Device Recall Viatrac 14 Plus Peripheral Dilatation Catheter see related information
Date Initiated by Firm May 06, 2009
Date Posted March 22, 2010
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-1178-2010
Recall Event ID 53474
510(K)Number K072798  
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
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.
Code Information Lot Number: 8121251.
Recalling Firm/
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
Manufacturer Reason
for Recall
Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
FDA Determined
Cause 2
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 in Commerce 26
Distribution Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = ABBOTT VASCULAR-VASCULAR SOLUTIONS