# FDA recall Z-1284-2024

> **Medos International Sarl** · Class I · device recall initiated 2024-02-02.

## Product

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:    a) GS9080SD;    b) GS9090SD;    c) GS9095SD;   Vascular guide-catheter, single-use

## Reason for recall

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1284-2024
- **Recalling firm:** Medos International Sarl
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-02
- **Report date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Le Locle, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2024

## Citation

> AI Analytics. FDA recall Z-1284-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1284-2024. Source: US FDA. Licensed CC0.

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