A St. Jude heart device recall lawyer notes that St. Jude Medical, Inc. is recalling its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to battery failure. Two patients have reportedly died as a result of premature battery loss. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer.
For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated St. Jude heart device recall lawyer who can assist you throughout the legal process.
Important: The time you have to pursue a claim is limited. Contact us for more information.
St. Jude Initiates Recall on Nearly 400,000 Devices
The U.S. Food and Drug Administration (FDA) and St. Jude Medical are alerting patients, patient-caregivers and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts associated with St. Jude Medical ICDs and CRT-Ds. According to an article issued by Reuters on October 11, 2016, St. Jude Medical said it would recall roughly 400,000 of the implanted heart devices due to risk of possible rapid battery failure. In some cases, full battery depletion can occur within a day to a few weeks after the patient receives an ERI alert. Two deaths have been reportedly linked to the loss of defibrillation therapy as a result of premature battery loss.
To date, 841 devices were returned for analysis due to premature battery depletion. In addition to the two reported deaths, 10 people have reported fainting and 37 have reported dizziness from devices that could not provide adequate pacing therapy due to battery depletion. Recalled devices were manufactured before May 2015 and include the following ICD and CRT-D models:
- Fortify VR
- Fortify ST VR
- Fortify Assura VR
- Fortify Assura ST VR
- Fortify DR
- Fortify ST DR
- Fortify Assura DR
- Fortify Assura ST DR
- Unify Quadra
- Unify Assura
- Quadra Assura
- Quadra Assura MP
In a safety communication issued by the FDA, patients are advised to contact their physician if they feel a vibratory alert and register for home monitoring to alert the patient’s physician as well. If symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath occur, patients are advised to seek medical attention immediately.
How a St. Jude Heart Device Recall Lawyer Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective heart defibrillator may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
The Time You Have to Pursue a Claim is Limited. Contact Us Today.
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After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.