Z-1178-2010

Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by...

Name: Z-1178-2010 Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by...
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2009-05-06
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2009-05-06 / Terminated / root cause: labeling and UDI

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of 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... on 2009-05-06. The reason FDA records is "Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1178-2010
Status: Terminated
Initiated: 2009-05-06
Posted: 2010-03-22
Terminated: 2012-03-30
Recalling firm: Abbott Vascular
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.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 26
Distribution: Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
Product codes and lots: Lot Number: 8121251.

Product code LIT

K072798Class IIViatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions / cleared 2008-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)