Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Boston Scientific recalls ICDs, CRT-Ds

This article was originally published in The Silver Sheet

Executive Summary

Boston Scientific is recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because it made manufacturing process changes without proper FDA approval. The firm said March 15 that it will stop shipments and retrieve all field inventory of its ICDs and CRT-Ds, including the Cognis, Teligen, Confient, Livian, Prizm, Renewal and Vitality product lines. Boston Scientific said it learned of two unapproved manufacturing process changes during a "planned process review." The changes were validated but not submitted to FDA, the company said. Such changes, if material to the safety or effectiveness of the product, require PMA-supplement approval. The firm is acting "voluntarily and expeditiously" to resolve the issue and has seen "no evidence of any risk to patient safety," CEO Ray Elliott said. The company is not recommending explantation of already implanted devices, and its pacemakers and other products are not affected by the advisory
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036453

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel