Edwards Lifesciences has recalled 185 Fogarty Thru-Lumen Embolectomy Catheters (model 12TLW805F35) because the device's balloon may deflate much slower than intended. The balloon may take longer than 15 seconds to deflate during medical procedures, which can interfere with surgical timing and safety. These catheters were manufactured in the United States and distributed to healthcare facilities in Singapore, Taiwan, and Canada. If you or a loved one are scheduled for a procedure involving an embolectomy catheter, you should contact your healthcare provider to discuss any concerns.
A slow-deflating balloon can lead to prolonged vessel occlusion or difficulty removing the catheter during a surgical procedure, potentially causing vessel injury or surgical delays. No specific injuries have been reported in this data, but the defect poses a risk during critical vascular procedures.
Contact healthcare provider or manufacturer
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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