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 a specific TandemHeart Pump Kit model that may fail to prime due to an assembly error. This could cause problems with the temporary circulatory support system used in medical treatments.

Why it’s dangerous

The pump kit may not prime correctly due to an assembly error. This could lead to improper circulatory support during medical treatment, potentially causing complications.

Who’s affected

Patients using the TandemHeart Pump 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 the serial number on the pump kit. The affected models have serial numbers starting with 00142577 through 00142961.

Brand
Cardiac Assist
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on the pump kit to confirm if it is in the affected range.

✎ GovInfoNow

Questions people ask

What is the specific model of pump kit being recalled?

The TandemHeart Pump Kit model with serial numbers 00142577 through 00142961.

Why is this pump kit being recalled?

Due to an assembly error that may cause failure to prime, which could affect circulatory support during medical treatment.

Is there a fix or remedy for this issue?

The recall record does not specify a remedy.

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-1948-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1948-2020 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-1948-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1948-2020 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 Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support

Lower-risk recall