FDA-Device2018-10-24Class II
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Thoratec Switzerland GMBH
Hazard
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.
Sold states
U.S.: OR, AZ, CA, ID, WA, WI, NY, MA, CT, NJ, ME, RI, IL, MI, TN, OH, IN, KY, IA, AL, FL, NC, GA, SC, VA, MD, DC, PA, WV, DE, MN, MT, NE, CO, NM, UT, AR, MO, MC, TX, OK, LA, MS, ND
Affected count
1569
Manufactured in
Technoparkstrasse 1, N/A, Zurich, N/A, Switzerland
Products
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0103-2019Don't want to check this manually?
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