Cardiac Assist, Inc

Complete recall history across all FDA and CPSC categories — 14 total recalls

Cardiac Assist, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Cardiac Assist, Inc

Date Product Reason Class
Jun 30, 2023 LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy... Class II
Dec 5, 2022 SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... A software update (v1.1.5) has been developed to address the issue of Critica... Class I
Jul 21, 2022 TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... Critical Failure of the LifeSPARC controller when the software freezes or cra... Class I
Oct 14, 2021 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... Top label of the outer package of the collection kit Item 5820-3118 showed ex... Class III
Mar 19, 2021 Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheteriza... On 02/26/2021, it was found that there were incorrectly packaged Dilator sets... Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product:... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:... Failure to prime due to an assembly error Class II
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 573... Failure to prime due to an assembly error Class II
Nov 19, 2019 TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product ... The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Veno... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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