Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. |
| Product | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F |
| Quantity | 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 |
| Initiated | 2020-05-22 |
| Classified | 2020-10-08 |
| Terminated | 2021-10-15 |
| Recall number | Z-0090-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-0090-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85807/
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