Micro Therapeutics, Inc. (Medtronic) is recalling 26,065 Pipeline Vantage Embolization Devices with Shield Technology. These devices, which are implanted to treat brain aneurysms, have a risk of the internal braid narrowing, collapsing, or failing to properly fit against the blood vessel wall, particularly in devices with a diameter of 4mm or larger. This issue is typically discovered during follow-up imaging 6 to 12 months after the procedure and can lead to dangerous blood clots or serious health complications. This risk is higher for female patients who are 45 years of age or younger.
The device's braid may deform or collapse after being implanted, which can lead to thrombosis (the formation of blood clots) and other serious adverse events like stroke. These issues are often asymptomatic and are only detected during routine imaging months after the surgery.
Recall #: Z-1245-2025. This affects all unused devices. Higher risk in females <= 45 years of age.
Recall #: Z-1246-2025. Instructions for Use: Version Rev. A (01/2024).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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