# FDA recall Z-2969-2018

> **Inspire Medical Systems Inc.** · Class II · device recall initiated 2018-06-12.

## Product

Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020,     Product Usage:  The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

## Reason for recall

Incorrect use-by date on the device registration/patient file labels.

## Distribution

US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.

## Key facts

- **Recall number:** Z-2969-2018
- **Recalling firm:** Inspire Medical Systems Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-12
- **Report date:** 2018-09-12
- **Termination date:** 2019-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2969-2018

## Citation

> AI Analytics. FDA recall Z-2969-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2969-2018. Source: US FDA. Licensed CC0.

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