Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Recalled by Boston Scientific Corporation Due to One lot of the Extractor" Pro RX Retrieval...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Quantity: 39 units
Why Was This Recalled?
One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Where Was This Sold?
Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report