Recall Z-1564-2013— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-06-12, terminated 2013-11-19. It names 2 FDA 510(k) clearances: K103386, K021256. 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.. Reason: 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..
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-12
- Terminated
- 2013-11-19
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K103386 — MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
- K021256 — Z3 GUIDE CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.