Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F
FDA device recall Z-1564-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 15
- Distribution
- Internationally distributed: to countries of Germany and Poland.
- Date initiated
- 2013-06-12
- Date posted
- 2013-06-21
- Date terminated
- 2013-11-19
- Location
- Saint Paul, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS (K103386) | Medtronic, Inc. | 2011-02-11 |
| Z3 GUIDE CATHETER (K021256) | Medtronic Vascular | 2002-05-17 |