Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath

Recall Class: Class I

Date Recall Initiated: February 8, 2010

Product: Torflex Transseptal Guiding Sheath

This product was manufactured from April 11, 2007 through March 3, 2008 and distributed from April 2007 through May 2009.

See Related Recall Notice

Use:

These sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall (septum).

Recalling Firm:

Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, QC H4T 1A1
Canada

Manufacture:

Thomas Medical Products
65 Great Valley Parkway
Malvern, Pennsylvania 19355-1302

Reason for Recall:

During heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death.

Public Contact:

Customers may contact the company at 1-514-488-9802 or by email at mkhakhar@baylismedical.com

FDA District: Dallas

FDA Comments:

On February 8, 2010, the company notified its customers about the recall by overnight mail. The company instructed its customers to:

• STOP using the device.
• Return all unused products to the company.
• Return the acknowledgment form.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.