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Thoratec Switzerland GMBH recalls CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMa
Recalled November 6, 2019 · FDA recall Z-0221-2020 · Thoratec Switzerland
Hazard
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). · FDA Class I
Units
664 units (381 U.S. and 283 OUS)
Sold at
Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Description
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
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.
Manufacturer(s)
Thoratec Switzerland GMBH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →