# FDA recall Z-1803-2024

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2024-03-19.

## Product

Medtronic Intracoronary Shunts:    a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers:  31100;   b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers:  31125;   c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers:  31200

## Reason for recall

Potential for unsealed sterile packing.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1803-2024
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-19
- **Report date:** 2024-05-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2024

## Citation

> AI Analytics. FDA recall Z-1803-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1803-2024. Source: US FDA. Licensed CC0.

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