The Food and Drug Administration (FDA) started 2018 with a Class 1 recall of heart valve replacement devices. A Class 1 recall is the highest level of recall issued by the FDA. It is issued when there is a reasonable probability that a device could cause serious health issues, including death.
Cost of Device Failure
The valve replacements at issue are intended to prevent blood flow back through the valve when placed in the heart. They are designed for insertion and position of cardiovascular catheters in the heart.
The FDA found that the devices may fail due to an improper seal on the valve, which could allow blood to leak. This has the potential to cause an air embolism in the affected individual. The improper seal is at the sheath hub of the product and may allow the device’s cap to fall off and create a difference in pressure in the body.
The FDA noted that small patients and those with pre-exiting decreased pulmonary reserves were more at risk for experiencing the potential embolism, which could result in death.
The FDA said that the recall affects 112 devices which were made and distributed between January and May 2017. The product is manufactured by a Johnson and Johnson subsidiary named Sterilmed.
Healthcare professionals are instructed to immediately determine whether they have this product in stock and return any unused products.
The FDA stated that currently there are no known cases of injury due to the valve, but patients who received the device during surgery must be made aware. The company first recalled the device in June 2017.
In the United States, surgeons replace approximately 106,000 heart valves each year. Heart valve replacement, although usually successful, is not a permanent solution to valve problems since valves must be replaced approximately every ten to fifteen years.
Valve replacements break down more quickly in children and young adults than in older patients. A sign of a good valve replacement is when the patient can hear a clicking sound in their chest indicating the valve opening and closing. Heart valve issues do not always require valve replacement – some issues can be addressed through medication. Patients should always weigh all options prior to determining that implanting a medical device is the best solution.
Pennsylvania Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Help Victims of Defective Medical DevicesIf you or a loved one has been harmed by a defective medical device, contact a Pennsylvania defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. For a free consultation, call 800-369-0899 or 215-569-4000 or contact us online. We serve clients throughout the Philadelphia area and New Jersey including Philadelphia County, Chester County, and Delaware County.