Cardiac Assist, Inc recalls
Every recall we track for Cardiac Assist, Inc — 14 in all, from 2019–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Cardiac Assist, Inc peaked in 2020 (8); 14 since 2017.
All FDA recall records for Cardiac Assist, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 6 | 2 | 0 | 8 |
| 2021 | 0 | 0 | 1 | 1 | 2 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Cardiac Assist, Inc recalls
What to do if you have a recalled Cardiac Assist, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cardiac Assist, Inc recalls
7 shown- Lower riskMedical device
Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:
Cardiac Assist recalls LifeSPARC Pumps with possible uncured epoxy that could lead to early pump failure. Affected units include specific part numbers and kit models sold between 2020-2022.
Cardiac AssistJun 30, 2023 - Use cautionMedical device
Cardiac Assist, Inc recalls SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001.
Cardiac Assist recalls LifeSPARC Controller models 5900-0000 and 5900-0001 due to software freezing and data display issues that could cause critical failure during use.
Cardiac AssistDec 5, 2022 - Use cautionMedical device
Cardiac Assist, Inc recalls TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001.
TANDEM LIFE recalls LIFESPARC Controller models 5900-0000 and 5900-0001 due to critical software freezing that may cause data loss. Affected units have specific serial numbers listed in the recall notice.
TANDEM LIFEJul 21, 2022 - Lower riskMedical device
Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components:
Cardiac Assist recalls specific cardiac bypass kits due to incorrect expiration date labels on packaging. Affected kits may have safety risks if used without proper expiration verification.
Cardiac AssistOct 14, 2021 - UnratedMedical device
Cardiac Assist, Inc recalls Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem
Cardiac Assist recalls 14 kits of Protek Solo Venous Dilator Set with incorrect packaging that could be distributed to patients. Affected units include specific catalog numbers and serial lots.
Cardiac AssistMar 19, 2021 - Use cautionMedical device
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary
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.
Cardiac AssistMar 6, 2020 - Lower riskMedical device
Cardiac Assist, Inc recalls TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo
Cardiac Assist recalls TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) due to incorrect cannula size. This kit contains a 29Fr ProtekDuo instead of the required 24Fr ProtekSolo, which could lead to improper blood flow during cardiac support procedures.
Cardiac AssistNov 19, 2019
Cardiac Assist, Inc recall questions
How many recalls has Cardiac Assist, Inc had?
14 recalls from Cardiac Assist, Inc are on record with U.S. safety agencies, from 2019–2023.
What is the most recent Cardiac Assist, Inc recall?
Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:, dated Jun 30, 2023. Every Cardiac Assist, Inc recall is listed on this page, newest first.
Why are Cardiac Assist, Inc products recalled?
The most common reasons on record: Failure to prime due to an assembly error (8).
What should I do if I have a recalled Cardiac Assist, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cardiac Assist, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.