Class 2 Device Recall EndoVive

• Date Initiated by Firm: June 02, 2005
• Date Posted: July 07, 2005
• Recall Status: Terminated on December 13, 2006
• Recall Number: Z-0963-05
• Recall Event ID: 32383
• 510(K)Number: K031538
• Product Classification: Tube, Gastro-Enterostomy - Product Code KGC
• Product: Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820.
• Code Information: Lots 7511185, 7511184, 7423558, 7421294, 7421292, 7393128, 7411790, 7411788, 7411787, 7389202, 7410534, 7410533, 7407840, 7407839, 7407838 and 7421293.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: Kathy Thorp; 508-683-4026
• Manufacturer Reason for Recall: Two blades may be heat staked onto the stiletto instead of the expected one blade.
• FDA Determined Cause: Other
• Action: Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
• Distribution: Nationwide and Panama.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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