LivaNova 3/8X3/8X3/8 Y CONN Recall: Risk of Fire

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Contact the company & request your remedy

Recalling firmLivaNova USA Inc.14401 W 65th Way, N/A · Arvada, CO 80004-3503

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✎ GovInfoNow plain-language explainer

What happened, in plain English

LivaNova is recalling a specific type of 3/8X3/8X3/8 Y connector that has a fire risk. This recall affects units with the EC2105S/ 00803622129285 label. Using these connectors could lead to fire if not replaced.

Why it’s dangerous

The connector has a fire risk due to potential overheating. This can happen when the connector is used in medical devices without proper cooling. The fire hazard is serious and could cause injury.

Who’s affected

Users of medical devices that include this connector are affected. Those with the EC2105S/ 00803622129285 label on their connector are most at risk.

How to tell if you have this one

Check for the EC2105S/ 00803622129285 label on the connector. The connector is part of medical devices and was sold with the lot number LOT2004300008.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the connector if it has the EC2105S/ 00803622129285 label to prevent fire.

✎ GovInfoNow

Questions people ask

Is this recall for a specific medical device?

The recall is for a specific 3/8X3/8X3/8 Y connector used in medical devices, not the entire device.

How can I tell if my connector is affected?

Look for the EC2105S/ 00803622129285 label on the connector. Affected units were sold with lot number LOT2004300008.

What should I do if I have this connector?

Stop using it immediately and contact LivaNova for replacement or repair.

Take action

Contact LivaNova

We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2459-2020 — LivaNova LivaNova

Hello,

I own a LivaNova that is covered by recall Z-2459-2020 from LivaNova.

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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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-2459-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2459-2020 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.

LivaNova USA Inc. recalls 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

Stop using this now