If you or a loved one received a Boston Scientific Accolade pacemaker, you may have heard of the recall notice given out by the FDA and the company in concert when it was discovered that there was a battery defect that would trigger the device going into safe mode. The initial recall targeted 203,000 devices and was issued on December 2024, after four patients died and thousands suffered complications requiring explantation. However, according to a new recall notice, the FDA has stated that the issue now affects over a million American patients, which effectively makes it one of the largest medical device recalls in recent history.
The expansion of the recall simply means, horrifyingly, that patients who thought they were safe are now at risk and could face complications that could come at any given time since it is not known with a certainty when the device goes on safe mode, which may lead to the development of life-threatening arrhythmias, and in some cases, collapse and even sudden death. If you got fitted with a Boston Scientific pacemaker, it is important that you read this post carefully to know how to not only safeguard your health but also your legal rights which may be in jeopardy should you either give a written or oral statement to Boston Scientific representatives, or sign a release form in exchange for them to replace your Accolade pacemaker. The most important thing you can do right now is to keep reading so you can ensure that you make good health and legal decisions going forward.
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What the Recall Expansion Means for your Legal Rights and Health
The expansion of the Boston Scientific Accolade recall isn’t just some formal update; it is a sign that the battery defect is not only materially real, but that it is larger than originally thought, which carries significant health and legal implications for you and your loved ones.
Here’s what you need to know:
- The recall now encompasses 1.3 million devices nationwide, which means that if your loved one has a Boston Scientific pacemaker, you’re more likely to be affected as either a family member or as a patient. Previously, it was thought that the battery cathode defect was limited to a specific production run. However, it has been shown that multiple generations of devices are now affected.
- The battery defect leads to something called High Internal Cell Impedance, which effectively forces the device to go into Safety Mode which then leaves your heart to go into rhythm drops.
- The recall expansion is bizarrely a net positive because you now have a stronger legal claim against Boston Scientific as they cannot claim ignorance about the issue when the problem affects such a vast number of pacemakers they were required to manufacture safely.
How to Determine if Your Device is Affected
If you have a Boston Scientific pacemaker, the first thing you must do is locate your device identification card, which is usually provided to you by either your cardiologist or hospital at the time of the surgery. On this card, you shall find the model number, brand name and serial number of your device. Next, you want to check the FDA website or the Boston Scientific site to see if your device is on the list. Please note that ACCOLADE, PROACCOLADE, ESSENTIO and ALTRUA 2 pacemakers have all been hit with this new and updated recall notice. If your device is affected, please call your electrophysiologist immediately so you can schedule an in-person device interrogation. It is also important that you do not blindly rely on the software update pushed by Boston Scientific as there is a significant chance that you may need an explantation – see your doctor for more information on this.
Best Boston Scientific Accolade Pacemaker Lawyers – Call Us Today!
If you or a loved one was fitted by the Boston Scientific line of pacemakers, you may be able to recover substantial compensation via the filing of a product liability claim. At McCready Law, we have extensive experience representing patients that have been injured by defective medical devices, and we’ve recovered over $500 million for our clients. Regardless of where you live in the country, we can help with your claim, and in some cases, travel to where you are. Need to speak with us for clarity and more information? Call us NOW at (314) 481-63338 for your 100% FREE legal consultation. Thanks for choosing McCready Law, and we look forward to helping you