Z-1633-2008

6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular...

Name: Z-1633-2008 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular...
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2008-03-17
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2008-03-17 / Terminated / root cause: labeling and UDI

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a... on 2008-03-17. The reason FDA records is "Mislabeling: The part number on the product label packaging may not match the product". 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-1633-2008
Status: Terminated
Initiated: 2008-03-17
Posted: 2008-08-13
Terminated: 2011-07-07
Recalling firm: Abbott Vascular
Product: 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.
Product code: DQY Catheter, Percutaneous
Reason for recall: Mislabeling: The part number on the product label packaging may not match the product.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: 8011791

Product code DQY

K972484Class IIAcs Viking Guiding CatheterGuidant Corp. / cleared 1997-09-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)