FDA-Device2020-10-14Class II

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Siemens Medical Solutions USA, Inc.
Hazard

Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

Sold states
U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada
Affected count
N/A
Manufactured in
22010 SE 51st St, N/A, Issaquah, WA, United States
Products
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2021

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