If you’ve been following the Boston Scientific Accolade pacemaker recall debacle, you may have seen that the FDA alert as well as the public statements from the company itself have stated that there is a specific cutoff date, and this is 2018, as being the dividing line between unaffected and affected devices. However, the company hasn’t gone into great length to state why this date matters, and what really happened during the manufacturing process and why patients that received devices post this date are being informed they’re not out of the woods and may be victims of a defective device.
The battery cathode defect that affected over 2,500 individuals causing injuries to them as well as four deaths isn’t something that could be deemed as a quality control failure – it was an issue that was in fact known to the company which chose not only to continue the manufacturing process, but to also not inform patients who if had a choice in the matter may have chosen a safer pacemaker from a different line or company altogether. The issue, officially known as high internal cell impedance was identified during the manufacturing stage and was never rectified before the Accolade pacemakers were rolled out for use and implantation. Understanding this issue is key to knowing how the whole issue unraveled, and what the battery cathode manufacturing process is, and why September 2018 is the key cutoff date, and what this means for both your health and legal rights.
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The Boston Accolade Pacemaker Battery – What The Company Knew About Defect
Before we get into the battery cathode defect issue, it is important to understand the manufacturing process of the battery cathode, and why the defect matters for your claim.
Here’s the lowdown on the battery cathode issue for Accolade pacemakers:
- The cause of the defect is linked to a specific processing technique that is used during the battery cathode manufacturing that led to the deposition of high concentrations of lithium salt in the cathode material. This then created a chemical imbalance within the battery architecture that ended in high internal cell impedance with time.
- The defect affected mainly devices manufactured prior to September 2018 which is the year and month that the company changed its manufacturing process. However, the company has confirmed that even devices manufactured after this cutoff date may be affected as well.
- It is also important to note that not only does the issue manifest spontaneously, it takes time before it shows up. Therefore, you may be fine many years after implantation and then be told you need to come into your doctor’s office because they have reason to believe your battery may have developed high impedance.
Why The September 2018 Cutoff Date is Key for Your Claim
The date is significant for a number of reasons, with the first one being that Boston Scientific cannot claim they had no knowledge of the defect. The fact that they changed their manufacturing process after this date is ample evidence that it was aware of the issues and took steps to mitigate it, even when these steps weren’t sufficient to prevent all defects. In addition, the expansion of the recall to include devices made after 2018 is a clear sign that the corrective actions were insufficient, and that the issue was more endemic than originally opined.
Best Boston Scientific Accolade Recall Attorneys – Call Us Today!
If you were implanted with a Boston Scientific Accolade pacemaker and are wondering if you have rights when it comes to filing a claim in order to recover damages, McCready Law can help you determine this. Please call us NOW at (314) 481-63338 so we can perform a no-cost evaluation of your case, take a look at your medical records and give you a ballpark figure on what your claim is worth with regard to damages. We handle cases countrywide, and remember, the call is 100% FREE, and there is no legal obligation. The window is fast closing, so file your claim before your potential recovery ability diminishes. Thanks for choosing McCready Law, and we look forward to helping you.