# FDA recall Z-0623-2024

> **Medtronic Inc.** · Class II · device recall initiated 2023-11-20.

## Product

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

## Reason for recall

Seal defects could compromise the ability of the product packaging to maintain sterility.

## Distribution

US Nationwide distribution in the state of MN.

## Key facts

- **Recall number:** Z-0623-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-11-20
- **Report date:** 2024-01-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0623-2024

## Citation

> AI Analytics. FDA recall Z-0623-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0623-2024. Source: US FDA. Licensed CC0.

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