Use caution Medical device recall · FDA · Published March 6, 2020

Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk

Cardiac Assist recalls TandemLung Kit (DL31) with serial numbers 00142473 and 00142606 due to assembly error causing failure to prime. This may lead to improper circulatory support.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1954-2020Medical device Cardiac Assist ›

Use caution until it’s fixed

Failure to prime due to an assembly error

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Cardiac Assist is recalling TandemLung Kit (DL31) models with specific serial numbers because an assembly error could cause the pump to fail to prime. This means the device might not function properly, risking inadequate circulatory support for patients. Read more at govinfonow.com/recall/65698-cardiac-assist-tandemheart-pump-kit-recall-failure-to-prime-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65698-cardiac-assist-tandemheart-pump-kit-recall-failure-to-prime-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1954-2020

Cite this page

“Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65698-cardiac-assist-tandemheart-pump-kit-recall-failure-to-prime-risk. Based on FDA recall #Z-1954-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2020%22&limit=1).

The FDA announced on March 6, 2020, that Cardiac Assist, Inc. recalled TandemHeart pumps assembled into TandemLung Kit - DL31 kits due to a failure to prime caused by an assembly error. The agency classified the recall as Class II.

How to tell if you have it

Brand: Cardiac Assist
Product: TandemHeart pump in TandemLung Kit - DL31, Product: 5730-3118
Serial Numbers: 00142473, 00142606

The hazard

The recall addresses the hazard of failure to prime due to an assembly error. The product provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Context

GovInfoNow's records show Cardiac Assist, Inc. has issued six other recalls since November 19, 2019. Recent brand recalls include a June 30, 2023, recall for uncured epoxy risks in the LifeSPARC Pump and a December 5, 2022, software update recall for the LifeSPARC Controller. Other recent recalls of similar products include Thoratec HeartMate 3 LVAS Kits Recall (May 13, 2026) and CGuard Prime Carotid Stent System Recall (May 1, 2026).

How to tell if you have this one

Check for serial numbers 00142473 or 00142606 on the TandemLung Kit (DL31) product. This kit is used for temporary extracorporeal circulatory support with anticoagulant delivery.

Brand
Cardiac Assist
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distributions.

Recall number	Product, codes & lots	Quantity
Z-1948-2020	TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961	10
Z-1949-2020	TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142681 00142683 00142949 00142950 00142951	5
Z-1950-2020	TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972	15
Z-1951-2020	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142569 00142570 00142571 00142572 00142573 00142574 00142575 00142576 00142592 00142593 00142594 00142595 00142597 00142598 00142600 00142601 00142664 00142665 00142666 00142668 00142669 00142670 00142671 00142672 00142673 00142674 00142692 00142693 00142694 00142696 00142697 00142698 00142699 00142926 00142930 00142933 00142936 00142934	38
Z-1952-2020	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967	46
Z-1953-2020	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142676 00142677 00142678 00142679 00142680 00142910	6
Z-1954-2020	TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142473 00142606	2
Z-1955-2020	TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.; Serial Numbers: 00142463 00142464 00142465 00142469 00142470 00142471 00142472 00142478 00142479 00142480 00142481 00142482 00142483	13

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers 00142473 or 00142606 on the TandemLung Kit (DL31).

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distributions.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

Mar 6, 2020Firm started the recall
May 11, 2020FDA classified it Class II
May 20, 2020Published in FDA’s Enforcement Report
Nov 20, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65698-cardiac-assist-tandemheart-pump-kit-recall-failure-to-prime-risk">Cardiac Assist TandemHeart Pump Kit Recall: Failure to Prime Risk (GovInfoNow)</a>

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-1954-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1954-2020 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.