CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Check against the official notice below — it lists the full affected range.
The CentriMag Acute Circulatory Support System motor, sold under U.S. Model 102956 and OUS Model 201-10002, has been recalled due to reports of motor and pump issues caused by electromagnetic interference (EMI). A total of 664 units were distributed, including 381 units in the United States and 283 units internationally across numerous countries including Canada, Mexico, and various European and Asian nations. The affected motors have serial numbers ranging from L05333-0001 to L06608-0024.
The source document does not specify a remedy for consumers who possess this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Reason for recall: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). Distribution: 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 Un Quantity: 664 units (381 U.S. and 283 OUS) Lot/code info: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.