Class 2 Device Recall Concerto

• Date Initiated by Firm: July 15, 2005
• Date Posted: August 31, 2005
• Recall Status: Terminated on February 07, 2007
• Recall Number: Z-1456-05
• Recall Event ID: 32764
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
• Code Information: Lots 7575613, 7583594, 7715339 and 7730068.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 508-683-5190
• Manufacturer Reason for Recall: The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
• FDA Determined Cause: Other
• Action: Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.
• Quantity in Commerce: 115
• Distribution: Nationwide, Germany, Italy, Netherlands, Spain and Sweden.
• 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.