# FDA recall Z-0522-2024

> **Medtronic Inc.** · Class II · device recall initiated 2020-07-13.

## Product

Medtronic SynchroMed, Model A10

## Reason for recall

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens:  Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

## Distribution

Foreign Distribution

## Key facts

- **Recall number:** Z-0522-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2020-07-13
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2024

## Citation

> AI Analytics. FDA recall Z-0522-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0522-2024. Source: US FDA. Licensed CC0.

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