Medtronic Recalls Defibrillators Over Risk of Inadequate Energy Output
In July 2023, medical technology company Medtronic issued a recall of its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with a feature known as a “glassed feedthrough.” The recall, which has been classified as a Class I recall by the FDA, the most severe category, signifies that the use of these devices could potentially lead to serious injury or even death.
Parker Waichman LLP, a distinguished national product liability law firm, champions for the rights of victims affected by the recently recalled Medtronic’s ICDs and CRT-Ds. With a reputation for relentless advocacy and a record of success in the complex field of product liability, our law firm is now filing lawsuits across the country, seeking compensation on behalf of those who have suffered due to these defective medical devices. We offer a free consultation to evaluate potential claims. We also represent clients on a contingency fee basis, meaning we do not charge any fees unless we win your case. We are committed to delivering justice for victims nationwide and can be reached directly at 1-800-YOUR-LAWYER (1-800-968-7529).
Which Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) Were Recalled
The recall impacts multiple product lines that were distributed between October 13, 2017, and June 9, 2023. The affected products include:
- Cobalt XT,
- Cobalt,
- Crome,
- Claria MRI,
- Amplia MRI,
- Compia MRI,
- Viva,
- Brava,
- Visia AF,
- Visia AF MRI,
- Evera,
- Evera MRI,
- Primo MRI,
- Mirro MRI ICDs, and
- CRT-Ds.
In total, 348,616 devices have been recalled in the United States alone.
ICDs and CRT-Ds are devices implanted in the patient’s body to monitor and regulate heart rhythm and rate. These devices can automatically detect and treat life-threatening irregular heartbeats (arrythmia) by producing an electric shock, thereby restoring a normal heartbeat. Some devices can also offer cardiac resynchronization therapy to manage heart failure.
Reason for the ICDs and CRT-Ds Recalls
The recall was initiated following the discovery that these ICDs and CRT-Ds, especially those manufactured after 2017, might not deliver sufficient energy output when high voltage therapy is required due to inappropriate activation of the Short Circuit Protection (SCP) feature. This problem is notably more prevalent in devices with a glassed feedthrough configured to deliver therapy in the AX>B delivered pathway.
The potential lack of adequate energy output during an arrhythmia episode could be life-threatening as it might not correct the irregular heartbeat, leading to cardiac arrest, serious injury, or death. Patients implanted with these devices also face additional risks if further surgical procedures are required to remove and replace the malfunctioning device.
Medtronic has reported a total of 28 incidents and 22 injuries associated with this issue, although no deaths have been recorded.
Who May be Affected
The recall affects patients who have been implanted with the specified ICDs and CRT-Ds. Health care providers who implant and manage patients with these devices should also take note of this recall.
What Actions Are Required
Medtronic has issued an Urgent Medical Device Correction Notice outlining the necessary actions to address this software issue. These actions include:
- Not replacing devices prophylactically for this issue.
- Reprogramming all high voltage therapy pathways B>AX in all therapy zones to minimize the risk.
- Prioritizing reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
- Encouraging patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming.
- Monitoring patients remotely following normal clinical protocol.
- Contacting Medtronic Technical Services or your local representative if certain symptoms are observed. These symptoms could indicate either a device or lead-related issue.
For any questions or concerns regarding this recall, customers are encouraged to contact their local Medtronic representative or Medtronic Technical Services at 1-800-929-4043.
The Importance of Filing a Product Liability Lawsuit If Harmed By Recalled Medtronic ICDs and CRT-Ds
The recent Class I recall of certain models of Medtronic’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) has raised important concerns about patient safety. If you or a loved one has suffered an injury due to one of these devices, you might be wondering what your next steps should be. One important consideration is the option of filing a product liability lawsuit. Here are some reasons why this could be the right choice.
- Hold Manufacturers Accountable – When medical device manufacturers fail to ensure the safety and efficacy of their products, they must be held accountable. By filing a lawsuit, you contribute to this process by shedding light on the issue and compelling the company to rectify the problem.
- Compensation for Damages – A product liability lawsuit can help victims recover the financial costs associated with their injuries. This can include medical expenses, such as the costs of additional surgeries to remove and replace the faulty device, hospital stays, medications, and ongoing therapy. It can also include compensation for lost wages if the injury prevented you from working, and non-economic damages for pain and suffering, emotional distress, and loss of enjoyment of life.
- Prevent Future Harm – By drawing attention to the device’s failure and the harm it has caused, you can help prevent others from suffering similar injuries. A lawsuit can exert pressure on the manufacturer to address the issue promptly and can raise public awareness about the potential risks of the device, leading to more stringent safety measures and regulations.
- Legal Representation is Essential – The complexities of a product liability case, particularly those involving medical devices, necessitate skilled legal representation. An attorney with experience in this field can navigate the complex legal and medical issues involved, work with experts to establish the link between the device and your injury, and advocate for your rights against large corporations.
To determine your eligibility for a product liability lawsuit, it’s crucial to consult with an experienced product liability attorney. This process can help you understand your legal rights and decide the best course of action. Legal teams can also help identify whether a class action lawsuit is in progress, as other patients may have experienced similar issues.
Always remember that every patient’s case is unique, and the decision to pursue a lawsuit should be made in consultation with a legal professional and based on your specific circumstances.
Understanding the Lawsuit Compensation Process in Product Liability Cases
When it comes to product liability cases, particularly those involving medical devices like the recently recalled Medtronic’s ICDs and CRT-Ds, the lawsuit compensation process can be intricate and lengthy. Here’s a simplified outline of what you might expect from the process:
- Consultation with One of Our Lawyers – The first step is to consult with an experienced product liability attorney. During this consultation, the attorney will review your case, assess the damages you’ve suffered, and determine the validity of your claim. Your lawyer will also explain the legal process ahead and what you can expect
- Investigation and Filing the Lawsuit – If your attorney agrees to take on your case, they will begin a comprehensive investigation. This step involves collecting all relevant medical records, testimonies, device records, and any other evidence that substantiates your claim. Once enough evidence is gathered, your attorney will file a lawsuit on your behalf.
- Discovery Process – Once the lawsuit is filed, both sides will enter the discovery phase, where they exchange information and evidence about the case. This process often involves depositions, where witnesses, including the victim, medical experts, and others, give sworn testimonies.
- Settlement Negotiations – In many cases, the defendant (in this case, Medtronic) may propose a settlement to avoid a court trial. Your attorney will negotiate on your behalf to ensure you get the maximum possible compensation. If an agreement is reached, you will receive your compensation, and the case ends here.
- Trial – If a settlement isn’t reached, the case will proceed to trial. Your attorney will present your case, including evidence and expert testimonies, to a judge or jury. The defense will also present their case. The judge or jury will then determine if the defendant is liable and, if so, how much compensation you should receive.
- Collection and Appeal – Once a verdict is reached, the defendant is legally obligated to pay the determined compensation. However, they might choose to appeal the decision, which can extend the process. If the appeal is unsuccessful, or once it is resolved, you should receive your compensation.
This process can be stressful and time-consuming. However, having a knowledgeable and experienced product liability attorney on your side can significantly ease the burden and improve your chances of securing the compensation you deserve. It’s essential to remember that each case is unique, and this process can vary based on the specifics of your case.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective product. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).