Zoll ICY Intravascular Heat Exchange Catheter Kit Recall: Potential Leaks

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Contact the company & request your remedy

Recalling firmZOLL Circulation, Inc.2000 Ringwood Ave · San Jose, CA 95131-1728

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Zoll is recalling its ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if the leaks cause fluid or medication to enter unintended areas of the body.

Why it’s dangerous

The catheter or start-up kit tubing may leak, potentially causing fluid or medication to enter unintended areas of the body. This could lead to complications such as infection or improper medication delivery.

Who’s affected

Healthcare professionals using the ICY Intravascular Heat Exchange Catheter Kit for central venous infusion. Those at highest risk are patients receiving treatments through this catheter system.

How to tell if you have this one

Check for the Zoll REF: 8700-0782-40 (IC-3893AE) model with central venous infusion capabilities. All lots of this product are affected.

Brand
Zoll
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product model and lot number to confirm if it matches the recalled items.

✎ GovInfoNow

Questions people ask

Is this recall affecting all units of the ICY Intravascular Heat Exchange Catheter Kit?

Yes, all lots of the Zoll REF: 8700-0782-40 (IC-3893AE) model are affected.

What should I do if I have this product?

The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model.

Could this leak cause serious harm?

The recall states potential leaks, but does not specify the risk of serious injury. The hazard level is low risk.

Take action

Contact Zoll

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

✉️ Open in email

Subject: Recall Z-0047-2022 — Zoll Zoll

Hello,

I own a Zoll that is covered by recall Z-0047-2022 from Zoll.

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-0047-2022 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0047-2022 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.

ZOLL Circulation, Inc. recalls Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion

Lower-risk recall