Boston Scientific Corporation has recalled 156 units of its Extractor Pro RX Retrieval Balloon Catheter because the devices are incorrectly labeled. The label indicates that a component called the skive hole is located above the balloon when it is actually below it, and vice versa. This recall affects catheters with UPN (REF) numbers M00547030 and M00547000. Medical facilities should stop using these devices immediately and contact the manufacturer to arrange for their return or replacement.
The incorrect labeling causes a mismatch between the indicated and actual position of the skive hole. This could lead to improper device orientation or malfunction during a medical procedure, potentially resulting in surgical delays or internal patient injury.
Instructions for Use: 51878205; Pre-Printed Pouch: 51368417
Instructions for Use: 51878205; Pre-Printed Pouch: 51368417
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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