Cardiac Assist TandemHeart Kit TS62/A15: 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 TandemHeart Kit TS62/A15 models with specific serial numbers because of an assembly error that may cause the pump to fail to prime. This could lead to blood clotting or other complications if the device is used without proper priming.

Why it’s dangerous

The assembly error may cause the pump to fail to prime, meaning it cannot properly circulate blood. This could lead to blood clotting or other complications if the device is used without proper priming.

Who’s affected

Patients using the TandemHeart Kit TS62/A15 for temporary circulatory support are affected. Those with the specific serial numbers listed are most at risk due to the assembly error.

How to tell if you have this one

Check the serial numbers on the TandemHeart Kit TS62/A15: 00142681, 00142683, 00142949, 00142950, and 00142951. The product provides 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 TandemHeart Kit TS62/A15 has one of the serial numbers: 00142681, 00142683, 00142949, 00142950, or 00142951.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The recall is due to an assembly error that may cause the pump to fail to prime, which could lead to blood clotting or other complications.

What should I do if I have this kit?

Check the serial numbers on your TandemHeart Kit TS62/A15. If it matches the listed serials, contact Cardiac Assist for further instructions.

Is there a fix for this issue?

The recall record does not specify a remedy, so no fix is mentioned. Contact Cardiac Assist for assistance.

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-1949-2020 — Cardiac Assist Cardiac Assist

Hello,

I own a Cardiac Assist that is covered by recall Z-1949-2020 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-1949-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1949-2020 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: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides

Use caution until it’s fixed