Cardiac Patients: Class One Medical Device Recall

Cardiac patients should be aware of the Class I Recall involving Thomas Medical Products with the company’s Transseptal Sheath Introducer Kit, also known as HeartSpan, CHANNEL FX, and Torflex, Braided Guiding Introducer Kit. This medical device is used in cardiac patients to pass a heart catheter from one side of the heart to the other during cardiac surgery. It has reported that the tip of the medical device may break off, move through the heart and arteries as well as penetrate vital organs such as the heart or brain. Consequently, cardiac patients that experience this defect may be subject to emergency open heart surgery or suffer from injury such as heart attack, stroke or death.

Cardiac patients should be aware that cardiologists are in the process of being informed. Class I Recalls are the most serious types of recalls. Such recalls are usually generated following reports of life threatening injury and/or death. It is wise for cardiac patients to be aware of medical device defects. Cardiac patients may inform cardiologists about the defect. Though, it is not the responsibility of cardiac patients to be informed about medical devices or inform physicians. It is the responsibility of the manufacturer to inform cardiologists about medical device defects.

Cardiac patients and their families may not be aware that illness, stroke, heart attack or death may be caused by a defective medical device. This may appear to be an unexpected, but natural occurrence for an individual with heart disease. However, such is not always the case in medical devices that are subject to a Class I recall. Lawyers that focus on illnesses relating to defective medical devices invest in research to identify the true cause for unexpected injuries and death.

If you or a loved one has been seriously injured because of a defective Cardiac medical device, contact Burton Padove for a free consultation at 219-836-2200.