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.
FDA Recall Z-1178-2010 · Posted 2010-03-22
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Recall StatusTerminated
Product CodeLIT
Date Initiated2009-05-06
Date Terminated2012-03-30
Product Quantity26
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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