# FDA recall Z-1242-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-05-05.

## Product

Tornado Embolization Microcoil,    RPN                                          GPN    MWCE-18S-5/2-TORNADO	G08356  MWCE-18S-6/2-TORNADO	G08259  MWCE-18S-3/2-TORNADO-01	G47416  MWCE-18S-4/2-TORNADO-01	G47417  MWCE-18S-3/2-TORNADO-081800	G13102  MWCE-18S-3/2-TORNADO	G08261  MWCE-18S-4/2-TORNADO-081800	G13103  MWCE-18S-4/2-TORNADO	G08357  MWCE-18S-5/2-TORNADO-01	G47418  MWCE-18S-6/2-TORNADO-01	G47419  MWCE-18S-6/2-TORNADO-081800	G13105  MWCE-18S-5/2-TORNADO-081800	G13104  MWCE-18S-2/4-TORNADO-LEF	G09945  MWCE-18S-2/5-TORNADO-LEF-081800	G13108  MWCE-18S-4/3-TORNADO	G12924  MWCE-18S-2/3-TORNADO-LEF	G09944  MWCE-18S-2/3-TORNADO-LEF-081800	G13106  MWCE-18S-2/4-TORNADO-LEF-081800	G13107

## Reason for recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1242-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-05
- **Report date:** 2022-06-15

- **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-1242-2022

## Citation

> AI Analytics. FDA recall Z-1242-2022. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-1242-2022. Source: US FDA. Licensed CC0.

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