ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12 — Class II medical device recall Z-0090-2021
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2020-10-14, distributed in AZ, CA, FL, GA, IL, KY, MA, MI…. Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
| Recall number | Z-0090-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Issaquah, WA, United States |
| Recall initiated | 2020-05-22 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2021-10-15 |
| Distributed | AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 40568690042666 |
| Serial numbers | XR000002, XR000007, XR000008, XR000009, XR000011, XR000012, XR000013, XR000016, XR000018, XR000019, XR000021, XR000022, XR000023, XR000026, XR000027, XR000028, XR000029, XR000031, XR000035, XR000041, XR000044, XR000045, XR000048, XR000049, XR000120 and 308 more |
| Model numbers | 10855958 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0090-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.