# FDA recall Z-2159-2024

> **Inspire Medical Systems Inc.** · Class I · device recall initiated 2024-05-16.

## Product

Inspire Model 3028, IV Implantable Pulse Generator

## Reason for recall

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

## Distribution

Worldwide distribution - US Nationwide  and the country of Germany.

## Key facts

- **Recall number:** Z-2159-2024
- **Recalling firm:** Inspire Medical Systems Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-16
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Golden Valley, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2024

## Citation

> AI Analytics. FDA recall Z-2159-2024. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2159-2024. Source: US FDA. Licensed CC0.

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