FDA Device recall Z-0090-2021
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F by Siemens Medical Solutions Usa, citing due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0090-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-22 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV |
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.
Identifiers
| code_info | Model Number: 10855958 GTIN: 40568690042666 Serial Numbers: XR000665 XR000035 XR000405 XR000713 XR000714 XR…Model Number: 10855958 GTIN: 40568690042666 Serial Numbers: XR000665 XR000035 XR000405 XR000713 XR000714 XR000717 XR000720 XR000492 XR000493 XR000623 XR000692 XR000693 XR000427 XR000428 XR000429 XR000430 XR000431 XR000432 XR000434 XR000435 XR000437 XR000438 XR000648 XR000656 XR000658 XR000661 XR000568 XR000605 XR000606 XR000607 XR000608 XR000002 XR000596 XR000597 XR000600 XR000601 XR000694 XR000695 XR000587 XR000588 XR000120 XR000131 XR000653 XR000654 XR000698 XR000473 XR000474 XR000475 XR000480 XR000372 XR000373 XR000374 XR000380 XR000011 XR000168 XR000226 XR000227 XR000394 XR000479 XR000517 XR000518 XR000598 XR000602 XR000603 XR000007 XR000008 XR000012 XR000013 XR000018 XR000019 XR000022 XR000023 XR000028 XR000260 XR000265 XR000756 XR000759 XR000029 XR000609 XR000610 XR000486 XR000487 XR000488 XR000489 XR000213 XR000214 XR000216 XR000218 XR000220 XR000221 XR000222 XR000223 XR000224 XR0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0090-2021%22
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