Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc. recalls ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Recall date
May 22, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0090-2021
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc.
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

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