# K110493: Tandemheart Pump

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Sep 20, 2011 after 210 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K852698 (1985). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991783: AB-180 XC System, Model AB-180XC, Cardiacassist, Inc. (2000) Summary page 4.
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100, Levitronix, LLC (2003) Summary page 4.
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console, Levitronix, LLC (2008) Summary page 4.

## Most influential descendants
- K183623: LifeSPARC Pump, LifeSPARC Controller (2019), 1 descendant of its own
- K232132: LifeSPARC System (2023), 0 descendants of its own

## Recalls of this device
- Mar 6, 2020 · Class II · Z-1955-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1954-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1948-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1951-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1950-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1953-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1952-2020: Failure to prime due to an assembly error
- Mar 6, 2020 · Class II · Z-1949-2020: Failure to prime due to an assembly error

## Indications for use
The TandemHeart pump is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K110493
Methodology: https://510kreport.com/methodology