Z-1564-2013Class II

Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot #...

Name: Z-1564-2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot #...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2013-06-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-06-12 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding... on 2013-06-12. FDA classified it as Class II and gives the reason as "Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package". 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-1564-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Posted: 2013-06-21
Terminated: 2013-11-19
Recalling firm: Medtronic, Inc.
Product: Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: 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: Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Medtronic "Urgent Field Safety Notice" letter dated June 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter instructed customers to remove and quarantine all affected product within their inventory and return the affected product to Medtronic. For questions contact your local Medtronic representative.
Quantity in commerce: 15
Distribution: Internationally distributed: to countries of Germany and Poland.
Product codes and lots: Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1564-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1564-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)