Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


St. Jude Warning Letter Adds More Pressure On Firm’s Leads Division

This article was originally published in The Gray Sheet

Executive Summary

The company stresses that FDA’s letter does not identify any specific concerns about Durata or any other product, but the citation nonetheless states that the leads are “adulterated” due to quality system violations and “misbranded” due to adverse event reporting lapses.

You may also be interested in...

St. Jude Agrees To Pay $39m To Settle Shareholder Suit

The settlement, which does not include an admission of fault, puts an end to a long-running class action claim filed by investors who say they were misled by St. Jude’s failure to announce FDA safety concerns around the company’s Durata heart leads.

Another St. Jude ICD Lead Recall, But Impact May Be Limited

The recall, related to a manufacturing misstep for St. Jude's Optisure defibrillator leads, effects 447 devices and has not been linked to any patient injuries, the firm says.

St. Jude Announces CRM Approvals, Progress With Warning Letter

FDA approval of several St. Jude Medical’s new cardiac rhythm management devices, including a new defibrillator lead, suggest the agency is largely satisfied with the company’s steps to resolve a January 2013 warning letter.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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