Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk

Take action

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 specific TandemHeart ProtekDuo Kit models (DL31 RD) because an assembly error may cause the pump to fail to prime. This could lead to inadequate circulatory support for patients using the device.

Why it’s dangerous

An assembly error in the kit may cause the pump to fail to prime properly. This could result in the device not functioning correctly to provide temporary circulatory support, potentially leading to inadequate blood flow.

Who’s affected

Patients using the specific TandemHeart ProtekDuo Kit models (DL31 RD) with serial numbers 00142676-00142910 are affected. Those with the device are at risk of inadequate circulatory support if the pump fails to prime.

How to tell if you have this one

Check for the ProtekDuo Kit model DL31 RD with serial numbers starting with 00142676 through 00142910. The product provides 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 Device Serial Number
Look for the serial numbers 00142676 to 00142910 on the kit packaging or device.

✎ GovInfoNow

Questions people ask

What is the specific model of pump being recalled?

The specific model is the TandemHeart ProtekDuo Kit (DL31 RD) with serial numbers 00142676 to 00142910.

Why is this pump being recalled?

An assembly error may cause the pump to fail to prime, which could lead to inadequate circulatory support for patients.

What should I do if I have this pump?

The recall record does not specify a remedy, so contact Cardiac Assist directly for guidance.

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-1953-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1953-2020 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-1953-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1953-2020 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 - DL31 RD, Product: 5720-3631 - Product Usage: provides

Use caution until it’s fixed