Medtronic — Class II medical device recall Z-1564-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-07-03. Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affect
| Recall number | Z-1564-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2013-06-12 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-11-19 |
| Countries outside the US | DE, PL |
| Quantity | 15 |
| Reason classes | labeling |
| Lot numbers | 0006722866, 0006724224 |
| Model numbers | LA6IMAD, LA8EBU45SH |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1564-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.