Reported Nov 6, 2019 · Terminated
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the…
Thoratec Switzerland GmbH
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec Switzerland GMBH · Technoparkstrasse 1 · Zurich · N/A
Is this the product you have?
- CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
- Lot codes and dates
- U.S
- Model 102956 UDI07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
- Amount recalled
- 664 units (381 U.S. and 283 OUS)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Using this product could cause serious injury, illness or death — stop using it now.
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