# FDA recall Z-0110-2018

> **Medtronic Inc.** · Class II · device recall initiated 2017-09-10.

## Product

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

## Reason for recall

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0110-2018
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-09-10
- **Report date:** 2017-11-29

- **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-0110-2018

## Citation

> AI Analytics. FDA recall Z-0110-2018. Retrieved 2026-06-11 from https://api.ai-analytics.org/recall/Z-0110-2018. Source: US FDA. Licensed CC0.

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