Recall Z-0090-2021— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2020-05-22, terminated 2021-10-15. It names one FDA 510(k) clearance: K173618. Product: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F. Reason: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-22
- Terminated
- 2021-10-15
- Firm location
- Issaquah, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.