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 specific TandemHeart ProtekDuo Kit models (DL3) with serial numbers starting with 00142562 to 00142967. These kits may not prime properly due to an assembly error, potentially causing inadequate circulatory support for patients needing temporary extracorporeal circulation.

Why it’s dangerous

The assembly error can cause the pump to fail to prime, meaning it won't properly circulate blood. This could lead to inadequate circulatory support for patients who rely on the device for temporary extracorporeal circulation.

Who’s affected

Patients using the TandemHeart ProtekDuo Kit (DL3) for temporary circulatory support are most at risk. The recall applies to specific serial numbers listed in the notice.

How to tell if you have this one

Check if your TandemHeart ProtekDuo Kit (DL3) has a serial number from the list: 00142562 to 00142967. The product is used for temporary 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
Verify if your kit has a serial number from the list: 00142562 to 00142967.

✎ GovInfoNow

Questions people ask

What is the specific model of pump being recalled?

The TandemHeart ProtekDuo Kit (DL3) with product number 5720-3118.

Why is this pump being recalled?

Due to an assembly error that can cause failure to prime, potentially leading to inadequate circulatory support.

What should I do if I have the recalled pump?

Check if your kit has a serial number from the list: 00142562 to 00142967. If it does, 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-1952-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1952-2020 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-1952-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1952-2020 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: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary

Lower-risk recall