Over the last month the FDA has issued several warnings and recalls for heart devices, ranging from IVC filters to rotablator systems to intravascular devices. These recalls are not new: in the past five years, manufacturers have announced dozens of recalls for serious safety issues due to patient injuries and deaths. Our team of dangerous medical device lawyers highlights the most recent recalls below.
Although there has only been one recall to date, IVC filters are now linked to extremely serious risks, including filter fracture, perforation and migration. IVC filters are implanted in patients who cannot tolerate blood thinners to help stop blood clots from reaching the heart and lungs. There are two types of IVC filters: permanent and temporary. The most severe injuries are occurring in patients who received temporary filters that remain implanted for far too long.
Temporary filters are not designed to stay in patients for longer than a few weeks, or a few months, at most. If left in for longer periods of time, filters can break, not only failing to prevent dangerous blood clots, but also sending pieces of the filter to other parts of the body. Pieces of the IVC filter can puncture through major veins, arteries and organs, causing infections, embolism, or even death.
Hundreds of injury lawsuits have been filed against manufacturers of temporary IVC filters and we are currently accepting these claims. If you or someone you love had an IVC filter implanted contact our firm as soon as possible for a free case review. You may be entitled to compensation for current or future injuries.
The FDA recently released a Safety Communication to health care providers who treat patients for intravascular procedures. The devices at issue include catheters, guidewires, balloon angioplasty catheters, and implant delivery systems. These types of devices have special lubricious coatings to reduce the friction between blood vessels and the devices, giving doctors better grip and reducing injuries to patients.
Unfortunately, these coatings can separate from the devices and cause serious injury to patients. Separation can be caused by a wide range of factors, such as the patient's individual anatomy or the doctors' technique.
In the last year alone, there have been at least 500 reports made to the FDA regarding coating separation.This type of malfunctions can cause injuries such as: tissue death, pulmonary embolism or infarction, myocardial embolism or infarction, and wrongful death. Device coating defects often result in surgical interventions, heart attacks, and brain bleeds.
Since 2010 there have been 11 recalls from manufacturers due to coatings separating from devices. Most of these recalls were for guidewires. One of these guidewires, as part of a rotablator system, was recalled on November 27th of this year.
Boston Scientific recently announced its recall of RotaWire Elite core wires due to cracking and separation from the rest of the system. This type of defect can cause injuries such as blood in the sac around the heart, causing decreased heart function, heart attack, and fire fragment migration throughout the body. At least one patient death has been linked to this defect so far.
The recalled system is used to open narrowed arteries and cut plaque from the artery wall to improve blood flow to the heart. Patients may have to undergo emergency heart surgery if one of these guidewires separates from the rest of the system during surgery.
Our dangerous medical device lawyers are currently investigating cases of serious injury or death from recalled or defective devices like the IVC filter. We work exclusively on a contingency fee basis, meaning we do not charge anything unless we win you a settlement.