Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Leveen Coaccess Introducer Set. Disposable Recalled by Boston Scientific Corporation Due to Leveen Standard and Leveen Coaccess Needle Electrode System,...
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
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Quantity: 19,716 units distributed total all products
Why Was This Recalled?
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
Where Was This Sold?
Distributed in Brazil, Portugal and Hong Kong.
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