Class 2 Device Recall EndoVive Low Profile Replacement Button Kit

• Date Initiated by Firm: December 19, 2023
• Date Posted: February 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1153-2024
• Recall Event ID: 93794
• 510(K)Number: K161003
• Product Classification: Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
• Product: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
• Code Information: UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Rebecca Kinkead Rubio; 508-683-4000
• Manufacturer Reason for Recall: Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
• FDA Determined Cause: Under Investigation by firm
• Action: On December 19, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE PRODUCT REMOVAL letters. Customers were instructed to cease further distribution or use of any remaining affected product. Distributors should forward the notice to their customers to ensure the recall is carried out to the end-user level. Customers were instructed to discontinue use and segregate affected product. Customers will receive a Return Goods Authorization (RGA) number after completing and returning their Reply Verification Tracking Form (RVTF). Customers will receive credit for returned affected product. Reach out to your local Boston Scientific representative with any questions.
• Quantity in Commerce: 0 US; 74 OUS
• Distribution: International distribution to the country of Japan only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PIF