The latest in a series of recalls, the Cardiosave Hybrid and Rescue IABP devices have been flagged for unexpected shutdowns when improperly docked.
In a new development, the FDA has marked Getinge’s voluntary recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as a Class I recall—the most severe category indicating the potential for severe injury or fatality.
This follows an earlier announcement about the risk of device failures for these same Getinge IABPs, dated August 31, 2023.
Although characterized as a voluntary correction rather than a full product withdrawal, the recall pertains to Cardiosave Hybrid and Cardiosave Rescue IABP models distributed in the U.S. between March 6, 2012, and May 19, 2023. A total of 4,586 devices are involved, with the company initiating the recall on July 31, 2023.
Purpose of the Devices
These electromechanical systems are designed to inflate and deflate intra-aortic balloons, offering temporary left ventricular assistance via counterpulsation. They are primarily used in healthcare settings for patients suffering from acute coronary syndrome, undergoing cardiac and non-cardiac surgeries, or experiencing complications due to heart failure.
Reason for the Recall
The recall has been initiated due to issues stemming from incorrect docking of the devices. Specifically, if the IABP console is not appropriately secured to its cart, the device will default to battery operation and eventually shut down once the battery is depleted. This poses a significant health risk as it could result in interrupted therapy, leading to severe consequences like unstable blood pressure, insufficient blood supply to vital organs, and even death.
Between January 1, 2021, and June 2, 2023, 533 complaints related to these devices have been reported, including one fatality.
Who Is at Risk?
The recall impacts individuals receiving circulatory support through these IABPs and healthcare providers administering such treatments.
Instructions for Healthcare Providers
In an urgent medical correction notice dated July 31, 2023, Getinge issued guidelines for properly docking the IABP. The procedure involves releasing the latch on the cart and sliding the console until it locks in place, which is confirmed by an audible click and three ascending audio tones.
For Further Information
For more details about the recall, customers should contact their Getinge representative or the company’s technical support. Adverse reactions or quality issues can also be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
How to Know If You Have a Claim For Compensation?
Navigating the complexities of a product liability case can be difficult, especially when it comes to determining your eligibility for compensation. If you or a loved one has been affected by a defective product, such as a medical device, there are several factors to consider when assessing whether you have a valid claim for compensation.
Establishing the Basics
- Proof of Defect: The first step is to establish that the product was defective. This could be due to a design flaw, manufacturing error, or insufficient warning labels.
- Usage: It’s essential to demonstrate that you used the product as it was intended to be used.
- Harm or Injury: You must have suffered harm or injury as a result of using the defective product. This could be physical harm, emotional distress, or financial loss.
- Causal Relationship: You will need to establish a direct link between your use of the product and the harm you sustained. This is often the most challenging part and usually requires expert testimony.
Medical Records and Documentation
- Medical Records: Any medical records detailing the injury and treatments you received can serve as valuable evidence.
- Receipts and Bills: Financial records related to the purchase of the product and any subsequent costs incurred due to its use (like medical bills) can help establish your financial loss.
- Photographic Evidence: Photographs or videos showing the defective product and the injury can help corroborate your claim.
- Witness Testimonies: Accounts from people who witnessed the incident or are knowledgeable about your situation can further strengthen your case.
Consult Our National Law Firm
- Initial Consultation: Most law firms offer a free initial consultation to assess the merits of your case.
- Case Review: Skilled attorneys will review all the available evidence, perhaps consult with experts, and give you a realistic appraisal of your chances for compensation.
- No Win, No Fee: Some law firms operate on a contingency basis, meaning they only get paid if you win.
- National Coverage: For products distributed across state lines or nationally, it’s beneficial to consult firms with a broad jurisdictional reach.
- Experience: Attorneys who specialize in product liability cases will likely be more effective in navigating the specific challenges and nuances your case may present.
If you think you have a valid claim, it’s crucial to consult with legal experts to guide you through the process, ensure all the necessary evidence is compiled, and represent you effectively in any proceedings.
Remember, each case is unique, so professional advice tailored to your specific circumstances is essential.
If your a loved one suffered injuries due to a malfunctioning Intra-Aortic Balloon Pump, please reach out to us for a complimentary, no-obligation case evaluation. You and your family may be eligible for significant financial compensation. Specializing in product liability cases nationwide, Parker Waichman LLP is committed to helping victims secure the restitution they deserve.
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).
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