Urgent Recall Issued for Cardiosave Intra-Aortic Balloon Pumps Due to Risk of Sudden Shutdowns
The U.S. Food and Drug Administration (FDA) issued a notice to serve as an update to a previous announcement regarding the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs), devices that were previously highlighted for their risk of mechanical failure. This is a voluntary corrective action rather than a product withdrawal, as clarified by the U.S. Food and Drug Administration (FDA).
The FDA has categorized this as a Class I recall, indicating that the malfunction of these devices could potentially result in serious health complications or even fatality.
About the Recalled Devices
Recalled Devices:
- – Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
- – Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
Model Types:
- – Cardiosave Hybrid
- – Cardiosave Rescue
Distribution Period: March 6, 2012 – May 19, 2023
Units Distributed Across the U.S.: 4,586
Date of Company’s Initiation of Recall: June 5, 2023
Functionality of the Devices
These electromechanical systems inflate and deflate intra-aortic balloons to temporarily support the left ventricle of the heart via counterpulsation. When the balloon is appropriately positioned within the aorta, it operates in sync with either the patient’s electrocardiogram or arterial pressure waveform, inflating and deflating at optimal moments during the heart’s cycle. These devices are commonly employed in cases of acute coronary syndrome, heart or non-heart surgeries, and complications due to heart failure.
Reason Behind the Recall
The Cardiosave IABPs have been recalled due to their susceptibility to abrupt shutdown caused by electrical malfunctions within their Power Management Board or Solenoid Board. Usage of a malfunctioning device could lead to severe health consequences, such as fluctuating blood pressure, insufficient blood supply to vital organs, or even death. The manufacturing company has received 26 complaints but no reports of injuries or fatalities have been confirmed.
Who May Be Affected
- – Individuals who rely on circulatory support from a Cardiosave Hybrid or Rescue IABP
- – Medical professionals administering care via these devices
Recommended Actions
On June 5, 2023, the company sent out an Important Medical Device Advisory to all concerned parties. The advisory recommended:
- Ensuring an alternative IABP is at hand for continuing therapy
- Securing different means of hemodynamic support if no substitute for counterpulsation therapy is available
For further questions or concerns regarding this recall, customers should reach out to their company representative or call their technical support line between the hours of 8:00 a.m. and 6:00 p.m. Eastern Time, Monday through Friday.
Who May Be Eligible to File a Product Liability Lawsuit?
Given the nature of the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) recall, the following parties may be eligible to file a product liability lawsuit:
Patients: Individuals who were administered treatment using the recalled IABP and suffered adverse health outcomes as a result.
Estates or Dependents: In instances where device malfunction has led to a patient’s death, the deceased’s estate or family may be eligible to file a lawsuit.
Types of Injuries and Damages That Could Be Compensable
Types of Injuries:
- Physical Harm: This encompasses injuries like unstable blood pressure, inadequate blood supply to vital organs, or any injury that might occur due to the device shutting down unexpectedly.
- Wrongful Death: If a malfunction of the recalled IABP results in the death of a patient, the deceased’s family might be eligible for compensation.
- Psychological Harm: Emotional trauma or psychological disorders such as anxiety or depression stemming from the device’s failure or complications.
Types of Damages:
- Economic Damages: These would cover the measurable financial losses like the cost of medical treatments, surgical interventions, hospital stays, or any other medical expenses incurred due to the malfunctioning device.
- Non-Economic Damages: These could include compensation for pain and suffering, emotional distress, or loss of quality of life due to the device’s malfunction.
- Punitive Damages: In cases where it can be proven that the company was aware of the faults and failed to act, punitive damages could be awarded to deter future negligence.
- Reimbursement to Healthcare Providers: Institutions may seek reimbursement for the costs incurred for device replacements, repairs, or additional medical procedures required due to device failure.
- Legal Expenses: In certain jurisdictions, the claimant might be able to recover the legal fees spent during the lawsuit.
Given the complexities involved in such a lawsuit, especially one involving medical devices, it is highly advisable to consult with our legal experts who represent claims and their families in product liability lawsuits. We can provide personalized advice tailored to the specifics of your case.
.svg){kind=small}
.avif)
.avif)
