Cardiac Assist recalls

Cardiac Assist has 14 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 6 Sep 2023. 2 are still ongoing. The most frequent reason is device malfunction.

Total recalls14since 2020

Last 12 months0reported

Class I214% of total

Ongoing2latest 6 Sep 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 14%Class II 11 79%Class III 1 7%

Why cardiac assist is recalled

Product types

By year

2023214%
202217%
2021214%
2020964%

Ongoing cardiac assist recalls

2 active

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023Device	CLASS II	LifeSPARC Pump recalled by Cardiac Assist	Cardiac Assist	Packaging Defects	Nationwide
8 Dec 2021Device	CLASS III	Ship Kit, Procedure Kit, Protekduo LS - DL31 recalled by Cardiac Assist	Cardiac Assist	Packaging Defects	4 states

All cardiac assist recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023Device	CLASS II	LifeSPARC Pump recalled by Cardiac Assist	Cardiac Assist	Packaging Defects	Nationwide
25 Jan 2023Device	CLASS I	Ship Kit, Lifesparc, Controller And Accessories recalled	Cardiac Assist	Device Malfunction	Nationwide
5 Oct 2022Device	CLASS I	Tandem Life LivaNova Lifesparc Controller recalled by Cardiac Assist	Cardiac Assist	Device Malfunction	Nationwide
8 Dec 2021Device	CLASS III	Ship Kit, Procedure Kit, Protekduo LS - DL31 recalled by Cardiac Assist	Cardiac Assist	Packaging Defects	4 states
5 May 2021Device	CLASS II	Protek Solo Venous Dilator Set: dilator, vessel recalled	Cardiac Assist	Packaging Defects	Nationwide
20 May 2020Device	CLASS II	TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15 recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020Device	CLASS II	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020Device	CLASS II	TandemHeart pump is assembled into kits: TandemLife Kit Product recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020Device	CLASS II	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3 recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020Device	CLASS II	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29 recalled	Cardiac Assist	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.