The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1240-2022·Announced 2022-06-15

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.

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 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
Category
Medical Device — Vascular Embolization
Hazard
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 →

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