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Recall Observatory FDA recall evidence

Device 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.

Z-0221-2020

August 22, 2019

Class I

Product summary

Firm
Thoratec Switzerland GMBH
Event
Event 83895
Status
Terminated
Classification
Class I
Quantity
664 units (381 U.S. and 283 OUS)
Official record key
device-enforcement:Z-0221-2020

Official wording

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

Code information: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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