# FDA recall Z-1483-2022

> **Medtronic Inc** · Class II · device recall initiated 2022-06-24.

## Product

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.

## Reason for recall

Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1483-2022
- **Recalling firm:** Medtronic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-24
- **Report date:** 2022-08-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2022

## Citation

> AI Analytics. FDA recall Z-1483-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1483-2022. Source: US FDA. Licensed CC0.

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