In Vivo is part 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


St. Jude recall

This article was originally published in The Gray Sheet

Executive Summary

Firm recalls more than 5,000 of its 6-French Engage introducers used to implant catheters and electrodes into blood vessels during surgery while helping to prevent bleeding. The firm announced the action after learning that the device shaft may separate from the hub or the hub assembly may break, causing potentially life-threatening bleeding. The affected devices were produced between April 27 and June 3, 2010. St. Jude alerted customers in a June 24 letter. FDA placed the recall in the highest-risk Class I category





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