Cardiac Assist, Inc
Pittsburgh, PA
This page shows every FDA and USDA recall linked to Cardiac Assist, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
15
Total Recalls
2010
First Recall
2023
Most Recent
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-10...
Aug 25, 2023
· Device
Open, Classified
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000;
SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001...
Jan 19, 2023
· Device
Terminated
TANDEM LIFE LivaNova LIFESPARC Controller;
Controller and Accessories Model 5900-0000;
Controller Only Model...
Sep 23, 2022
· Device
Terminated
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.
Including the following com...
Oct 14, 2021
· Device
Open, Classified
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.
Catalog #: 5840-2417 - LS...
Mar 19, 2021
· Device
Terminated
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provid...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: TandemLife Kit
Product: 5740-0000 - Product Usage: provides tempo...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: pro...
Mar 6, 2020
· Device
Terminated
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory syste...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: prov...
Mar 6, 2020
· Device
Terminated
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides...
Mar 6, 2020
· Device
Terminated
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number
5740-2417 - Product Usage: The function of the 24Fr Pr...
Nov 19, 2019
· Device
Terminated
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly
The TandemHeart Transseptal Cannula Set-E...
Jan 10, 2011
· Device
Terminated