The U.S. FDA has issued a Class I recall, the most serious level of recall for the Zilver PTX drug-eluting stent from Cook Medical because of potential tip separation from the inner catheter inside the body. Our Brazoria County medical device injury lawyers clarify that a Class I recall means that the FDA has determined that the defective medical device has a reasonable probability of causing “serious adverse health consequences or death.”

In patients when tip separation from the inner catheter of the medical device occurs, the patient might:

• Require surgery to remove the broken catheter tip;
• Develop vascular occlusion and blockage;
• Have thrombosis;
• Require amputation;
• Suffer cardiac arrest; or
• Die.

In fact, Cook Medical has already received at least 13 complaints of stent tip separation, including two serious adverse health events, one of which was a death from the defective medical device. The recalled Zilver PTX drug-eluting stents were sent out to medical facilities between December 13, 2012 and April 16, 2013.

Cook Medical specifies that the problem resides in the medical device’s delivery system and not the stent itself. In addition, our Brazoria County medical device injury lawyers note that the Zilver Flex stent uses a different delivery system that has not been recalled. In the medical devices affected by the recall, an internal component of the delivery system does not meet established design criteria.

If you have had the Cook Medical Zilver PTX drug-eluting stent implanted in your body and you’re concerned that your unit might be subject to recall, contact your physician immediately.

Adverse Health Consequences from Defective Medical Device Implants can be Costly and Debilitating

Another defective medical device implant is currently the subject of thousands of lawsuits and serious controversy. That device is the transvaginal surgical mesh implant used in pelvic organ prolapse repair. Attorneys all over the nation, including the Brazoria County medical device injury lawyers at Denena Points, PC, have begun helping seriously injured women seek fair financial compensation for the terrible harm they’ve suffered from the defective implants.

And a cardiac implant, St. Jude Medical’s Riata pacemaker, was recalled due to defective leads. Affected patients are often at great risk should they undergo corrective surgeries to exchange the device or its leads. So most of them simply have to monitor the situation and suffer because correcting the implant is too dangerous. Click the link to read about the Riata pacemaker lead recall.

Contact the Brazoria County Medical Device injury Lawyers if You’ve Suffered Injury from a Defective Medical Device

We understand how a defective implant or other medical device failure can change your life and lead to permanent injury or debilitating medical conditions. We’ve worked with other patients similarly injured to help them obtain the just financial recoveries they deserve. Call us at 281-369-4363 or reach us through our online contact form to schedule your free, no obligation legal consultation to discuss your case and evaluate your eligibility for financial compensation. We never charge you attorneys’ fees unless we win your case, so there’s no financial risk to you. Call us today, and let our 16 years of experience help you recover.

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