# FDA recall Z-1797-2024

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

## Product

Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010,

## Reason for recall

Potential for unsealed sterile packing.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1797-2024
- **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-1797-2024

## Citation

> AI Analytics. FDA recall Z-1797-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1797-2024. Source: US FDA. Licensed CC0.

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