Health product recall

Tornado, Nestor and Hilal Embolization Microcoils

Brand(s)
Last updated

Summary

Product
Tornado, Nestor and Hilal Embolization Microcoils
Issue
Medical devices - Performance issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Tornado Embolization Microcoils More than 10 numbers, contact manufacturer. MWCE-18S-6/2-TORNADO-01 MWCE-18S-3/2-TORNADO-01 MWCE-18S-6/2-TORNADO MWCE-18S-4/2-TORNADO-01 MWCE-18S-5/2-TORNADO-01
Nestor Plantinum Embolization Coi More than 10 numbers, contact manufacturer. MWCE-18-7-10-NESTER MWCE-18-7-3-NESTER MWCE-18-5-2-NESTER MWCE-18-3-2-NESTER MWCE-18-7-2-NESTER MWCE-18-7-5-NESTER
Hilal Embolization Microcoils More than 10 numbers, contact manufacturer. MWCE-18-0.5-0-HILAL-01
Nestor Embolization Microcoils More than 10 numbers, contact manufacturer. MWCE-18-3-3-NESTER-01 MWCE-18-5-3-NESTER-01 MWCE-18-7-3-NESTER-01 MWCE-18-2-2-NESTER-01 MWCE-18-3-2-NESTER-01 MWCE-18-7-4-NESTER-01 MWCE-18-7-8-NESTER-01 MWCE-18-5-2-NESTER-01 MWCE-18-7-5-NESTER-01 MWCE-18-7-2-NESTER-01 MWCE-18-7-6-NESTER-01 MWCE-18-5-5-NESTER-01

Issue

Cook Medical identified during manufacturing that an unintended small stainless-steel cannula may be contained in the loading cartridge of these devices. This loading cartridge is manufactured by an external supplier.

Recall start date: May 6, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Neurology
Companies

Cook, Inc.

750 Daniels Way, Bloomington, Indiana, United States, 47404

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64203

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