Centerline Biomedical has recalled 80 units of the IOPS Guidewire 2 (model REF ATW-2, Lot Number 2404-2005) because the protective coating on the wire may peel off while the device is in use inside a patient's blood vessels. This sensorized wire is used by medical professionals to navigate through vasculature to help place catheters. While no injuries have been reported, healthcare facilities must stop using the affected lot immediately and contact the manufacturer to arrange for its return or replacement.
The wire's coating can peel off (delaminate) during a procedure, potentially releasing fragments into the patient's bloodstream or causing the device to malfunction, which could lead to serious vascular injury.
Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
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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