# FDA recall Z-0090-2021

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2020-05-22.

## 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.

## 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

## Key facts

- **Recall number:** Z-0090-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-22
- **Report date:** 2020-10-14
- **Termination date:** 2021-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issaquah, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2021

## Citation

> AI Analytics. FDA recall Z-0090-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0090-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*