Z-0040-06

Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

Name: Z-0040-06 Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Creator: Boston Scientific Corporation
Published: 2005-09-23
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-09-23 / Terminated

FDA source

Boston Scientific Corporation began a recall of Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS on 2005-09-23. The reason FDA records is "Incorrect implantation may cause serious health complications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0040-06
Status: Terminated
Initiated: 2005-09-23
Posted: 2005-10-28
Terminated: 2006-10-24
Recalling firm: Boston Scientific Corporation
Product: Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Product code: LNM Agent, Bulking, Injectable For Gastro-Urology Use
Reason for recall: Incorrect implantation may cause serious health complications
FDA root 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: M00572600 =7844 kits ;M00572500=859 kits
Distribution: Nationwide :
Product codes and lots: All codes

Product code LNM

K042882Class IIEnteryx Injection CatheterBoston Scientific Corp / cleared 2004-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)