FDA Device recall Z-1245-2021
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 by Medtronic Vascular, citing sterility may be compromised due to an unsealed pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-15 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
Product
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Reason
Sterility may be compromised due to an unsealed pouch
Identifiers
| code_info | Lot Code: 220712186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.