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.

Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is programmed to repeatedly deliver and remove dialysis solution may produce increased Intraperitoneal Volume (IIPV). Intraperitoneal Volume (IIPV) is described as overfilling of the abdominal cavity.

Intraperitoneal Volume (IIPV) is known to cause serious breathing difficulty, hernias of the abdomen or diaphragm, pulmonary dysfunction, hypertension, hydrothorax, pericardial effusion and peritonitis. Dialysis patients that are children or are seriously ill are at an increased risk of injury from the affected models of Baxter’s Dialysis System.

Some physicians may still be using Baxter’s HomeChoice and HomeChoice PRO. If they are still using Baxter’s Dialysis Systems, they are being advised by the FDA to inform dialysis patients about the risk associated with HomeChoice and HomeChoice PRO.

Millions of Becton, Dickinson and Company catheter systems are involved in a recall because of a defect in the product that may result in injury or death to a user. The direct flaw of the catheter system involves the risk of an air embolism and leakage of blood or therapeutic fluids. These risks pose an additional risk of serious injury or death.

Becton Dickson received reports that air was entering through the septum disk. Catheter system failures were reported on units that were distributed from November 2009 to November 2009.

Catheters are used in hospitals to treat a variety of medical conditions, including, but not limited to: