Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula
Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.
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 medical device recall involving an unintended foreign body in the loading cartridge. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, consistent with a High severity rating.
Plain-English summary
Cook Incorporated is recalling specific lots of Hilal Embolization Microcoils (models MWCE-18-1.0-0-HILAL-01 and MWCE-18-0.5-0-HILAL-01) due to a manufacturing defect. The loading cartridges included with these devices may contain a small, unintended stainless-steel cannula.
The recall affects 106,033 units distributed nationwide in the United States and internationally. Affected lot numbers include 14212811, 14215685, 14212247, 14212812, 14212814, 14215682, 14361413, 14361416, 14285326, 14285328, 14285330, 14297289, 14361412, 14445407, 14444454, 14477949, and 14477950.
Healthcare facilities and providers who have received affected devices should discontinue use and contact Cook Incorporated for instructions. Patients who may have been treated with these devices should consult their healthcare provider if they have questions or concerns.
The recalled product
- Product
- Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
- Manufacturer
- Cook Incorporated
- Hazard
- foreign-body-contamination
- device-defect
Distribution
Distributed nationwide across the United States.
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