Home / Recalls / Thoratec Switzerland GMBH / Z-0221-2020

Z-0221-2020 Class I Terminated

Recalled by Thoratec Switzerland GMBH — Zurich

FDA device recall Z-0221-2020 was initiated by Thoratec Switzerland GMBH on August 22, 2019 and is designated Class I. Reason for recall: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). The recall status is terminated (terminated April 26, 2024). Affected quantity: 664 units (381 U.S. and 283 OUS).

Recall Details

Product Type: Devices
Report Date: November 6, 2019
Initiation Date: August 22, 2019
Termination Date: April 26, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 664 units (381 U.S. and 283 OUS)

Product Description

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

Reason for Recall

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

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.

Code Information

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