Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk

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Contact the company & request your remedy

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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardiac Assist is recalling TandemLife Kit pumps (model 5740-0000) because an assembly error can cause the pump to fail to prime. This means the pump might not function properly when used for temporary circulatory support, which could lead to complications for patients needing this life-saving treatment.

Why it’s dangerous

The pump may not prime correctly due to an assembly error, meaning it could fail to circulate blood properly. This could lead to inadequate blood flow during critical medical procedures where the device is used for temporary circulatory support.

Who’s affected

Patients using the TandemLife Kit for temporary circulatory support are affected. Those with medical conditions requiring this device are at higher risk.

How to tell if you have this one

Check for the TandemLife Kit (model 5740-0000) with serial numbers 00142463 through 00142483. The product 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 Pump Serial Number
Verify your TandemLife Kit has a serial number between 00142463 and 00142483.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled pump?

The recalled model is TandemLife Kit (product code 5740-0000).

Why is this pump being recalled?

An assembly error can cause the pump to fail to prime, which may lead to improper blood flow during temporary circulatory support.

How can I tell if my pump is affected?

Check the serial number on your TandemLife Kit; affected units have serial numbers from 00142463 to 00142483.

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-1955-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1955-2020 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-1955-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1955-2020 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: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary

Use caution until it’s fixed