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.
What this means for you
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 MWCE-1
- Manufacturer
- Cook Incorporated
- Hazard
- foreign-object
- device-malfunction
Distribution
Distributed nationwide across the United States.
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