FDA Recalls Johnson & Johnson Heart Device

The FDA has issued a Class 1 recall on a Johnson & Johnson heart device. The Agilis Steerable Introducer Sheath is used to insert cardiovascular catheters in the heart.

The sheath has a valve, which is designed to prevent blood from flowing back through the valve. In more than 100 of these devices, the device’s seal had either too much glue or not enough. According to the FDA, this defect can allow excess blood to leak into the heart or cause embolisms.

What is a Class 1 Recall?

About 110 devices made and distributed between Jan. 1 and May 5 are included in the recall. A Class 1 recall from the FDA is the strictest recall. It is used for faulty devices that may cause serious injury or death.

“Class 1 recalls indicate a serious danger to patients. If you have experienced an issue with this device, report it to the FDA and seek counsel from a personal injury attorney,” said Attorney Walter Clark, founder of Walter Clark Legal Group.

Our firm has been handling personal injury cases throughout the California Low Desert and High Desert communities for over 30 years. With a 95% success rate, the California personal injury attorneys at Walter Clark Legal Group will fight to hold those responsible for your loss accountable and win compensation to cover medical bills, lost wages, and pain and suffering. If you have been injured by a defective product and want to discuss your legal options, contact us today for a free consultation with an experienced personal injury lawyer. We have offices in Indio, Rancho Mirage, Victorville, and Yucca Valley and represent clients through the entire California Low Desert and High Desert communities.

DISCLAIMER: The Walter Clark Legal Group blog is intended for general information purposes only and is not intended as legal or medical advice. References to laws are based on general legal practices and vary by location. Information reported comes from secondary news sources. We do handle these types of cases, but whether or not the individuals and/or loved ones involved in these accidents choose to be represented by a law firm is a personal choice we respect. Should you find any of the information incorrect, we welcome you to contact us with corrections.

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