Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk

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Recalling firmCardiac Assist, Inc240 Alpha Dr, N/A · Pittsburgh, PA 15238-2906

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardiac Assist is recalling TandemLung Kit (DL31) models with specific serial numbers because an assembly error could cause the pump to fail to prime. This means the device might not function properly, risking inadequate circulatory support for patients.

Why it’s dangerous

The pump may not prime correctly due to an assembly error, which can lead to improper circulatory support. This could cause the device to fail during use, potentially harming the patient.

Who’s affected

Patients using the TandemLung Kit for temporary circulatory support are affected. Those with the specific serial numbers listed are most at risk.

How to tell if you have this one

Check for serial numbers 00142473 or 00142606 on the TandemLung Kit (DL31) product. This kit is used for temporary extracorporeal circulatory support with anticoagulant delivery.

Brand
Cardiac Assist
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers 00142473 or 00142606 on the TandemLung Kit (DL31).

✎ GovInfoNow

Questions people ask

What is the specific model being recalled?

The TandemLung Kit (DL31) with serial numbers 00142473 and 00142606.

Why is this recall happening?

An assembly error in the kit can cause the pump to fail to prime, which may lead to improper circulatory support.

What should I do if I have this product?

Check the serial numbers on the TandemLung Kit (DL31). If you have the listed serial numbers, contact Cardiac Assist for further instructions.

Take action

Contact Cardiac Assist

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

✉️ Open in email

Subject: Recall Z-1954-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1954-2020 from Cardiac Assist.

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-1954-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1954-2020 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.

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary

Use caution until it’s fixed