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.
Sterility may be compromised due to an unsealed pouch
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.
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.
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.
Check for the model number LA6EBU30 on the catheter packaging or label. Units sold with lot code 220857555 are affected.
Verify the model number LA6EBU30 and lot code 220857555 on the catheter packaging.
The recall indicates a potential sterility risk, so it should not be used until the remedy is confirmed. However, the remedy is not specified in the recall notice.
The recall notice does not provide specific action steps for affected users.
Check for model number LA6EBU30 and lot code 220857555 on the packaging or label.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1248-2021 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-1248-2021 from Medtronic Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
