# FDA recall Z-0561-2020

> **LivaNova USA Inc** · Class I · device recall initiated 2019-08-22.

## Product

VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only  for vagal nerve stimulation (VNS) therapy

## Reason for recall

Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

## Distribution

U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR.    OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT

## Key facts

- **Recall number:** Z-0561-2020
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-22
- **Report date:** 2020-01-01
- **Termination date:** 2024-03-28

- **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-0561-2020

## Citation

> AI Analytics. FDA recall Z-0561-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0561-2020. Source: US FDA. Licensed CC0.

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