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U.S. Department of Health and Human Services

Class 1 Device Recall Boston Scientific

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  Class 1 Device Recall Boston Scientific see related information
Date Initiated by Firm September 23, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on October 24, 2006
Recall Number Z-0040-06
Recall Event ID 33529
510(K)Number K042882  
PMA Number P020006 
Product Classification Agent, Bulking, Injectable For Gastro-Urology Use - Product Code LNM
Product Enteryx Procedure Kit
Order No.: M00572600 -US and M00572500 -OUS
Code Information All 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 2		 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 M00572600 =7844 kits ;M00572500=859 kits
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.
510(K) Database 510(K)s with Product Code = LNM and Original Applicant = BOSTON SCIENTIFIC CORP.
PMA Database PMAs with Product Code = LNM and Original Applicant = Boston Scientific Corp.
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