Z-0665-2007

Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm...

Name: Z-0665-2007 Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm...
Creator: Cook, Inc.
Published: 2007-02-28
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-02-28 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer... on 2007-02-28. The reason FDA records is "Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0". 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-0665-2007
Status: Terminated
Initiated: 2007-02-28
Posted: 2007-03-29
Terminated: 2007-05-29
Recalling firm: Cook Incorporated
Product: Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
Product code: DQY Catheter, Percutaneous
Reason for recall: Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via telephone on 2/28/07 and instructed to return the product.
Quantity in commerce: 20 units
Distribution: Illinois, North Carolina and South Carolina.
Product codes and lots: Lot 1820419.

Product code DQY

K052036Class IIAtb Advance Pta Dilatation CatheterCook, Inc. / cleared 2005-08-25

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)