Why has it taken so long for this recall? The recall is for Torflex Transseptal Guiding Sheath by Baylis Medical Company Inc. The date the recall was initiated was February 8, 2010. The product was sold April 2007 through May 2009.
This is a Class 1 recall which is 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.
Reason for the 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.
To learn more about this recall - go to Sheath recall
I am going to investigate further how many injuries, death, etc and the time line. I suspect that many injuries and deaths could have been avoided if the recall was issued sooner than 10 months after the last sale. The consequences of this type of product failure is too high.
Is anyone else interested in knowing how many unplanned open heart surgeries occurred because of this issue in 2007, 2008, 2009, and 2010? (as well as permanent injury, deaths, and AMI/Strokes.)