Class 1 Device Recall Boston Scientific

• Date Initiated by Firm: September 23, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on October 24, 2006
• Recall Number: Z-0041-06
• Recall Event ID: 33529
• Product Classification: Endoscopic Injection Needle, Gastroenterology-Urology - Product Code FBK
• Product: Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS
• Code Information: All lots codes
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Pl; Natick MA 01760-1536
• For Additional Information Contact: Cindy Finney; 508-683-4678
• Manufacturer Reason for Recall: Incorrect implantation may cause serious health complications
• FDA Determined Cause: Other
• Action: Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. . Physicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided to assist in their communication to the patient. Patient Letter / Patient Phone Script: A letter and phone script, from the physician to the patient, will be provided to the physician to assist in the physician's communication to patient. The letter informs the patient of the recall and asks them to contact their physician and the Patient Phone Script provides a template to initiate a discussion with the patient. Physicians Participating in Post Approval Studies: All physicians that are participating in post approval studies will be sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone script will be provided to assist in their communication to the patient. Internal Review Boards (IRBs): All IRBs that are participating in post approval studies will be sent, via FedEx, a IRB Letter and the Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided. Boston Scientific has posted the recall to their website:http://www
• Quantity in Commerce: M00572650=4080 Single; M00572630 =217 Single
• Distribution: Nationwide :
• 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.