Agency classClass IIOur severity:High FDA (Devices)·Z-1242-2022·Announced 2022-06-15

Tornado Embolization Microcoils recalled for unintended cannula in loading cartridges

Cook Incorporated is recalling certain Tornado Embolization Microcoils due to unintended stainless-steel cannulas in loading cartridges. The foreign objects may affect device function.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device containing an unintended foreign object (stainless-steel cannula) in the loading cartridge. The presence of a foreign object in a medical device constitutes a risk-of-harm situation that could affect proper device function. The source text does not indicate reported injuries or deaths.

Plain-English summary

Cook Incorporated is recalling multiple lots of Tornado Embolization Microcoils. The loading cartridges included with these devices may contain a small, unintended stainless-steel cannula that was not intended to be present in the product.

The recall affects approximately 106,033 units distributed nationwide in the United States and internationally. Multiple lot numbers are included in this recall.

Healthcare providers who have received or are using these devices should refer to Cook Incorporated for information about affected lot numbers and guidance on appropriate actions to take.

The recalled product

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…
Manufacturer: Cook Incorporated
Category: Medical Device — Vascular Intervention / Embolization
Hazard: foreign-object
device-malfunction
Affected units: 106,033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · foreign object