Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

CentriMag Acute Circulatory Support System Motor Recalled by Thoratec Switzerland GMBH Due to Reports have been received of the CentriMag Systems...

Date: August 22, 2019
Company: Thoratec Switzerland GMBH
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Thoratec Switzerland GMBH directly.

Affected Products

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

Quantity: 664 units (381 U.S. and 283 OUS)

Why Was This Recalled?

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Thoratec Switzerland GMBH

Thoratec Switzerland GMBH has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report