Z-2754-2011

Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic...

Name: Z-2754-2011 Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic...
Creator: Medtronic Vascular
Published: 2011-06-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-06-08 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Vascular began a recall of Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway... on 2011-06-08. The reason FDA records is "Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve". 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-2754-2011
Status: Terminated
Initiated: 2011-06-08
Posted: 2015-06-26
Terminated: 2012-04-17
Recalling firm: Medtronic, Inc.
Product: Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Product code: DQY Catheter, Percutaneous
Reason for recall: Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.
Quantity in commerce: 5 units
Distribution: Nationwide distribution: USA including states of: CA, FL, and MA.
Product codes and lots: Lot # : 0005199588

Product code DQY

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)