# FDA recall Z-0462-2021

> **LivaNova USA Inc** · Class II · device recall initiated 2020-09-28.

## Product

VNS Therapy¿ AspireSR¿ Generator

## Reason for recall

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

## Distribution

U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA     O.U.S.: Argentina, Finland and Peru

## Key facts

- **Recall number:** Z-0462-2021
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-28
- **Report date:** 2020-11-25
- **Termination date:** 2022-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0462-2021

## Citation

> AI Analytics. FDA recall Z-0462-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0462-2021. Source: US FDA. Licensed CC0.

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