Urgent Recall: Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) Due to Potential Battery Charging Failures
The Food and Drug Administration (FDA) has issued a Class I recall, the most severe recall category, for Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) distributed by Datascope/Maquet/Getinge. These devices, crucial for providing circulatory support, may present serious risks to patients if they malfunction.
What Are These Medical Devices?
The Cardiosave Hybrid and Rescue IABPs are sophisticated electromechanical systems that inflate and deflate intra-aortic balloons. This helps provide temporary support to the left ventricle, aiding in maintaining the heart’s rhythm. These pumps work in concert with the patient’s electrocardiogram or arterial pressure waveform, ensuring that the balloon inflates and deflates correctly during each cardiac cycle. They are primarily employed during episodes of acute coronary syndrome, various surgical procedures, and in complications arising from heart failure in adults.
Reason for the Recall
Datascope/Maquet/Getinge identified a potential fault in the printed circuit board assembly (PCBA) located within the battery charging path. This malfunction might lead to the unexpected shutdown of the device. Should this occur, the device may lose its charging capacity due to an electrical surge in the Power Management Board Charging Path Circuit.
The ramifications of using a malfunctioning pump include:
- Unstable blood pressure.
- Injury, such as inadequate blood supply or harm to a vital organ.
While Datascope/Maquet/Getinge has received 252 complaints about the devices, there have been no recorded instances of injury or death due to the malfunction.
Who This Recall Could Affect
- Patients who have received or are receiving circulatory support from a Cardiosave Hybrid or Rescue IABP.
- Health care professionals administering care using these devices.
Recommended Course of Action
On June 5, 2023, Datascope/Maquet/Getinge issued an advisory letter to all affected customers. They emphasized the following:
- Do not remove the battery from the device when it’s at 80% charge or higher and is still charging.
- If there’s an absolute necessity to remove the battery before it’s fully charged, follow the stipulated steps provided in the Urgent Device Correction Letter to ensure patient safety and device integrity.
If you have any questions or require further clarity on this recall, please contact Datascope/Maquet/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1. They are available from Monday to Friday between 8:00 a.m. and 6:00 p.m. (Eastern Time).
Lastly, if you or a loved one has been affected or injured due to the malfunction of one of these devices, it might be in your best interest to consult with a product injury lawsuit lawyer to understand your rights and potential remedies.
What Damages Could be Awarded in a Lawsuit?
Filing a lawsuit, especially in the context of product liability or personal injury, often serves multiple purposes. Let’s discuss the reasons why someone might file a lawsuit and then delve into potential damages that could be awarded.
Why File a Lawsuit?
- Compensation for Losses and Suffering: One of the primary reasons individuals pursue lawsuits is to seek compensation for physical injuries, emotional trauma, or financial losses they’ve incurred due to the actions or negligence of another party.
- Holding Parties Accountable: A lawsuit can hold manufacturers, corporations, individuals, or other entities accountable for faulty products, negligence, or wrongful actions.
- Prevention of Future Harm: By bringing issues to light and holding parties accountable, lawsuits can force changes in business practices or production methods. This can help prevent others from suffering the same injuries or losses in the future.
- Legal Obligation: In some cases, individuals might be legally obligated to pursue action, especially if there’s potential harm to the public.
- Closure: For many, pursuing a lawsuit offers emotional closure, ensuring that what happened to them is legally acknowledged.
- Public Awareness: High-profile lawsuits can draw public attention to potential dangers, leading to increased awareness and even policy or regulatory changes.
Potential Damages in a Lawsuit
In legal terms, “damages” refer to the monetary compensation awarded to a person who has been harmed due to the fault of another. Damages can be:
- Compensatory Damages: Meant to compensate the plaintiff for the harm suffered. This can include:
- Medical Expenses: Costs incurred for treating injuries resulting from the defendant’s negligence or wrongdoing.
- Lost Wages: Compensation for lost income due to injury or any other related cause.
- Pain and Suffering: Compensation for physical pain and emotional distress.
- Loss of Consortium: Compensation for the loss of companionship or relationship due to the injury.
- Property Damage: Reimbursement for property that was damaged or destroyed.
- Punitive Damages: Awarded in cases of extreme negligence or malicious intent, these damages are meant to punish the defendant and deter similar behavior in the future.
- Nominal Damages: A small amount awarded when a harm is demonstrated, but the plaintiff cannot prove a monetary loss.
- Special Damages: These are quantifiable monetary losses resulting from the defendant’s wrongdoing. They are specific to the individual plaintiff’s situation.
- General Damages: Compensation for non-monetary damages that are not quantifiable, like pain and suffering or loss of reputation.
If you or someone you know believes they have a case for a lawsuit, it’s important to consult with legal counsel. An attorney can provide valuable legal advice specific to your situation, helping you understand what damages you might be entitled to and guiding you through the legal process.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like these defective Cardiosave Hybrid and Rescue IABPs. For your free consultation, contact our national product liability law firmtoday by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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