Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-1564-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 12, 2013

Date Posted: July 3, 2013

Recall Number: Z-1564-2013

Event ID: 65458

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.

Status: Terminated

Product Quantity: 15

Code Information:

Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.

Distribution Pattern:

Internationally distributed: to countries of Germany and Poland.

Voluntary or Mandated:

Voluntary: Firm initiated