Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter nationwide in the United States after labeling inconsistencies were found. The label misstates whether the skive hole is above or below the balloon. The recall is active as of 2025. Stop using the device immediately and follow manufacturer instructions.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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Extractor Pro RX Retrieval Balloon Catheter is used in interventional procedures to retrieve devices. The device is a specialized medical tool used by healthcare professionals.
Labeling errors can lead to misplacement risks during procedures and misinterpretation of device orientation.
This recall is not described as part of a broader industry pattern in the provided data.
The labeling error could delay procedures or lead to improper device use in clinical settings, potentially affecting patient outcomes.
Find model numbers on the device packaging and IFU documents; UDI-DI on packaging and labeling
Refunds or replacements are coordinated through the manufacturer; expect communication via recall notice or letter
Keep all recall notices, communication records, and replacement confirmations; photograph packaging and model numbers
Product: Extractor Pro RX Retrieval Balloon Catheter. UPN REF: M00547030 (9-12mm Below) and M00547000 (9-12mm Above). Distribution: US nationwide in CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA. Quantity: 156 units. Recall date: 2025-08-28. Status: Active.
No injuries or incidents have been reported in the provided data.
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