Cook recalls two Hilal Embolization Microcoil models due to potential small stainless-steel cannula in loading cartridges. Affected units include specific serial numbers and lot codes. Consumers should check their device for these identifiers.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Cook is recalling two specific models of Hilal Embolization Microcoils because some loading cartridges may contain a small, unintended stainless-steel cannula. This could pose a risk of injury if the cannula becomes embedded in tissue during medical procedures.
The loading cartridges for these medical devices might include a small, unintended stainless-steel cannula. If this cannula becomes embedded in tissue during a procedure, it could cause injury. However, the risk is low as this is a rare manufacturing defect.
Medical professionals using the Hilal Embolization Microcoils for procedures like angiography are most at risk. Patients undergoing these procedures may also be affected if the cannula causes injury.
Check for the model numbers RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499) or RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498). Also look for the specific lot numbers listed in the recall notice.
Look for the model numbers RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499) or RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) on the device packaging or label.
Check if your device's lot numbers match the list provided in the recall notice: 14212811, 14215685, 14212247, etc.
The loading cartridges may contain a small, unintended stainless-steel cannula that could become embedded in tissue during medical procedures.
Check for the model numbers RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499) or RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) and verify if your lot numbers match the list provided in the recall notice.
No, the recall does not require immediate discontinuation. Affected devices should be checked for the specific model and lot numbers listed.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1240-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1240-2022 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
