# FDA recall Z-1247-2021

> **Medtronic Vascular** · Class II · device recall initiated 2021-01-15.

## Product

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75    Model Number: LA6EBU375

## Reason for recall

Sterility may be compromised due to an unsealed pouch

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1247-2021
- **Recalling firm:** Medtronic Vascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-15
- **Report date:** 2021-03-17
- **Termination date:** 2023-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2021

## Citation

> AI Analytics. FDA recall Z-1247-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1247-2021. Source: US FDA. Licensed CC0.

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