# FDA recall Z-1762-2025

> **Cook Incorporated** · Class II · device recall initiated 2025-04-17.

## Product

Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)

## Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

## Distribution

worldwide - No US distribution.

## Key facts

- **Recall number:** Z-1762-2025
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-17
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1762-2025

## Citation

> AI Analytics. FDA recall Z-1762-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1762-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*