medical Class I Updated 2019-11-06

Thoratec Switzerland GMBH recalls CentriMag Acute Circulatory Support System Motor, U.S. Model

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
View official government recall

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