# K222038: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott (Formerly Thoratec Corporation)
- Decided: Dec 8, 2022 after 150 days
- Product code: QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FDA final order for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure: named in the summary without a submission number

## Most influential descendants
- K234118: CentriMag™ Acute Circulatory Support System (2024), 0 descendants of its own

## Recalls of this device
- Oct 10, 2025 · Class II · Z-1099-2026: Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock 

## Indications for use
The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients’ blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Source page: https://510kreport.com/device/K222038
Methodology: https://510kreport.com/methodology