An FDA recall has been issued on Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators. The recall was issued due to a manufacturing error, with 48 units in the US recalled as the units pose a risk of causing patients serious injury or death. This is a Class I recall – the most serious of all FDA recalls, issued on January 22, 2018.
Patients who have the Medtronic ICD or CRT-D device and their caregivers, along with healthcare providers treating patients with heart rhythm issues or heart failure have been alerted to the recall. Patients who have one of the faulty medical devices must have it removed and replaced for their own safety.
This medical device is used to pace heart rhythms. It is implanted beneath the skin on the upper chest area.
When the heart rhythm slows (bradycardia), an electrical shock is triggered. If the heart rhythm is dangerously rapid, the unit slows the pace.
Medtronic, the manufacturer, is recalling 48 specific units due to a manufacturing defect in which the gas mixture within the device may prevent it from delivering the electrical charge needed to revive the patient in cardiac arrest, or to stimulate the heart when the rhythm dangerously slows.
Medtronic is unable to identify which of the 48 recalled devices is prone to failure or when the device may fail, and cannot predict the number of high-voltage charges may occur prior to complete device failure. Initial testing has revealed failures occurring in 23 percent of the devices, with 7.7 percent failing after only two charges.
Medtronic reports that the devices were sent through a manufacturing process that introduced the risk of internal electrical arcing, leading to the permanent loss of device function. The 48 affected devices include units from the following product lines of CRT-Ds and ICDs produced by Medtronic, Inc.:
If you or a loved one has one of these recalled devices, it is imperative that you get legal help. Medical device manufacturers must be held accountable when their products fail. Manufacturers of medical devices are represented by teams of defense attorneys who are tasked with protecting the manufacturer from significant financial losses.
At Meyers & Flowers, we level the playing field. As a team of winning trial attorneys with an extensive record of favorable outcomes, we take on any adversary with total confidence and professionalism. If you or a family member has suffered an adverse event from one of these devices, or must undergo device replacement surgery, we urge you to contact us to learn about your legal right to compensation.
Our team of trial attorneys is prepared to assist patients who have one of these faulty devices by filing a legal action against the manufacturer. Not only does the device pose a serious risk of injury or death, the surgical replacement of the device puts a patient at risk, particularly elderly persons who are struggling with heart failure. All surgical procedures carry the risk of complications, and replacing a ICD or CRT-D has a specific set of risks:
When a medical device manufacturer allows a faulty device onto the market, the manufacturer must compensate the victim appropriately. The amount paid in compensation can vary widely, and it is expected that the manufacturer and their legal team will attempt to pay out as little as possible – that is when our team of trial attorneys gets involved. The lawyers for the manufacturer may contact you and advise you that you have no need to retain legal representation – not true.
Your rights must be protected vigorously. The damages pursued on your behalf must include the following:
Our aggressive medical device litigation team is made up of attorneys who have dedicated their professional careers to seeking justice for injured patients. We have an extensive track record of successful verdicts and settlements and are known for our excellent legal work in this arena, and for our personal dedication to the people we serve.
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