Medtronic 6F Launcher Guide Catheter Recall: Sterility Risk from Unsealed Pouch
Medtronic recalls 6F Launcher Guide Catheter 100 cm EBU 3.0 (LA6EBU30) due to potential sterility compromise from unsealed pouch. Affected units sold with lot code 220857555.
Lower-risk recall
Sterility may be compromised due to an unsealed pouch
Contact the company
What happened, in plain English
Medtronic is recalling a specific type of catheter because an unsealed pouch could compromise sterility. This means the catheter might not be sterile when used, increasing infection risk during medical procedures. Read more at govinfonow.com/recall/63376-medtronic-6f-launcher-guide-catheter-recall-sterility-risk-from-unsealed.
Source Summary by GovInfoNow · govinfonow.com/recall/63376-medtronic-6f-launcher-guide-catheter-recall-sterility-risk-from-unsealed · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1248-2021
Cite this page
“Medtronic 6F Launcher Guide Catheter Recall: Sterility Risk from Unsealed Pouch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63376-medtronic-6f-launcher-guide-catheter-recall-sterility-risk-from-unsealed. Based on FDA recall #Z-1248-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2021%22&limit=1).
Why it’s dangerous
The catheter's pouch may not seal properly, allowing contaminants to enter. This could lead to infections during medical procedures if the catheter is not sterile when used.
Who’s affected
Healthcare professionals using this catheter for medical procedures are most at risk. Patients receiving the catheter during procedures could face infection if the sterility is compromised.
How to tell if you have this one
Check for the model number LA6EBU30 on the catheter packaging or label. Units sold with lot code 220857555 are affected.
- Brand
Medtronic Vascular- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1245-2021 | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35; Lot Code: 220712186 | 1 unit |
| Z-1246-2021 | Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40; Lot Code: 220754416, 220754417 | 9 units |
| Z-1247-2021 | Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375; Lot Code: 220772561, 220772562 | 10 Units |
| Z-1248-2021 | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30; Lot Code: 220857555 | 137 units |
What to do — step by step
Check Product Details
Verify the model number LA6EBU30 and lot code 220857555 on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1248-2021 (January 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1248-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.