Articles Posted in Medical Device Recall

Guidant, LLC, maker of a cardiac defibrillator, pled guilty to criminal violations of the Food and Dug Administration Cosmetic Act which requires that medical device companies disclose risks of serious injury and death that are associated with their products. The Guidant defibrillator was used in cardiac surgery to produce a shock to restart the heart when the device detects that the heart fails.  Guidant apparently was aware that there were short circuit failures in their Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155), but failed to disclose this information to the proper authorities or the public.

The FDA’s Office of Criminal Investigations spent four years investigating this case before determining that criminal allegations must be brought against the manufacturer. The affected Guidant defibrillator models were designed to detect and treat irregular heart rhythms, but when they fail due to short circuiting can result in sudden death momentarily. In the end, Guidant admitted to making a false statement about the Ventak Prizm 2DR device and failing to notify the FDA that the company made a correction to the Contak Renewal devices in order to reduce the risk of sudden death.

Guidant, a wholly-owned subsidiary of Boston Scientific Corporation, has now been presented with the largest criminal penalty imposed on a medical device company that failed to meet FDA requirements in the Cosmetic Act.

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.