FDA recall Z-1242-2022

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

Status

Ongoing

Initiation date

2022-05-05

Report date

2022-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1242-2022