# FDA recall Z-0683-2019

> **Medtronic Inc.** · Class II · device recall initiated 2018-10-03.

## Product

Medtronic MiniMed 630G 6025805-003_C, Rx Only    Medtronic MiniMed 670G 6025805-005_B, Rx Only    Medtronic MiniMed 640G (International)

## Reason for recall

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

## Distribution

US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY

## Key facts

- **Recall number:** Z-0683-2019
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-10-03
- **Report date:** 2019-01-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0683-2019

## Citation

> AI Analytics. FDA recall Z-0683-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0683-2019. Source: US FDA. Licensed CC0.

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