Class I Recall for Baylis Medical Torflex Transseptal Guiding Sheath

The <"">Torflex Transseptal Guiding Sheath has been recalled under a Class I recall by the Baylis Medical Company Inc., the U.S. Food and Drug Administration just announced. 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.

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.

This recall involves Torflex Transseptal Guiding Sheaths with Model Number TF8-38-62-S and Lot Numbers S21244, S21903, S21940, S22739, and S22739X1. 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).

The recalled Baylis Medical Company’s Torflex Transseptal Guiding Sheaths were manufactured from April 11, 2007 through March 3, 2008 and were distributed from April 2007 through May 2009. The recalling firm is Baylis Medical Company Inc.
5959 Trans-Canada Highway,
Montreal, QC H4T 1A1
Canada and the manufacture is Thomas Medical Products
65 Great Valley Parkway,
Malvern, Pennsylvania 19355-1302. The related Thomas Medical Products recall notice can be accessed at:

On February 8, 2010, the company notified its customers about the recall by overnight mail. The company instructed its customers to immediately stop using the device, to return all unused products to the company, and to return the acknowledgment form.

Baylis Medical can be reached by telephone at 1-514-488-9802 or by email at 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 at

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