PlainRecalls
FDA Devices Moderate Class II Terminated

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Reported: October 14, 2020 Initiated: May 22, 2020 #Z-0090-2021

Product Description

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.

Details

Units Affected
N/A
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
Location
Issaquah, WA

Frequently Asked Questions

What product was recalled?
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: N/A.
Why was this product recalled?
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0090-2021.