FDA recall Z-0090-2021

Siemens Medical Solutions USA, Inc. · Class II · device

Product

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-05-22
Report date
2020-10-14
Termination date
2021-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Issaquah, WA, United States

Primary source

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