Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) Lawsuit Lawyers

Dangerous Medical Device Recall: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs)

The U.S. Food and Drug Administration (FDA) has recently issued a Class I recall, the highest level of urgency, for the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs). This recall has significant implications for both healthcare providers and patients, affecting over 4,500 devices distributed in the U.S. Here’s an in-depth look at what has prompted this action and what it means for those who might be affected.

The Cardiosave Hybrid and Rescue IABPs

Manufactured and distributed by Datascope/Maquet/Getinge, these devices are electromechanical systems used primarily to support the heart’s left ventricle temporarily. Positioned in the aorta, they inflate and deflate in sync with the cardiac cycle, assisting with acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

The Issue Behind the Recall

The reason for this grave recall lies in a defect that may cause the devices to shut down unexpectedly. The issue stems from electrical failures in the Power Management Board or Solenoid Board (Power Source Path), leading to a potentially life-threatening event.

Although Datascope/Maquet/Getinge has reported 26 complaints, there have been thankfully no reports of death connected to this malfunction. However, the gravity of potential risks cannot be ignored, as affected pumps could lead to unstable blood pressure, vital organ injuries, or even fatalities.

Who May Be Affected?

• Patients receiving circulatory support: Those using a Cardiosave Hybrid or Rescue IABP are directly at risk due to this malfunction.
• Health care personnel: Medical professionals utilizing these devices must be aware of the recall and take necessary measures to ensure patient safety.

Manufacturer Instructions and Support

On June 5, 2023, Datascope/Maquet/Getinge issued an Important Medical Device Advisory to all affected customers. This included guidelines such as ensuring an alternative IABP is available and providing alternative hemodynamic support if no other means are available to continue therapy.

For further information and support, customers have been encouraged to contact Datascope/Maquet/Getinge Technical Support at their hotline or consult additional resources like the Medical Device Recalls database.

Reporting Problems to the FDA

The FDA has urged healthcare professionals and consumers to report any adverse reactions or quality problems experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

The recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps is a sobering reminder of the essential vigilance required in the medical field. It brings into sharp focus the importance of robust quality control and post-market surveillance in safeguarding patient lives.

Patients and healthcare providers must remain informed and vigilant to ensure that these critical devices function as intended. This recall serves as a significant milestone in ongoing efforts to improve medical device safety and emphasizes the necessity for collaboration between regulatory authorities, manufacturers, healthcare providers, and patients to mitigate risks and protect public health.

Beginning a compensation claim for a defective medical device, such as the recalled Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs), can be an intricate process. If you or someone you know has been affected by this recall, taking legal action may be a necessary step. Here’s a guide on how to start your compensation claim:

1. 1. Gather Evidence
      • Medical Records: Collect all relevant medical records that detail the use of the device and any adverse effects or injuries that may have occurred.
      • Communication: Save any correspondence with healthcare providers, the manufacturer, or any other involved parties.
      • Device Information: Note down the model and serial number of the defective device, along with any related purchase or usage documentation.
   2. Consult Our Legal Professionals
      • Call Parker Waichman LL to Speak With an Experienced Attorney: Our national defective product law firm focuses its practice in medical device litigation and personal injury claims.
      • Initial Consultation: Our firm offers free initial consultations to discuss the specifics of your case and evaluate its merits.
   3. Notify Involved Parties
      • Send a Notice: Your attorney may send a notice to the device manufacturer, healthcare provider, and possibly your insurance company, informing them of the claim.
   4. File a Formal Complaint if Needed
      • Legal Filing: If a settlement cannot be reached informally, your attorney may proceed to file a formal complaint in the appropriate court.
   5. Work with Your Attorney Throughout the Process
      • Cooperate Fully: Provide all necessary documentation and be readily available to your attorney.
      • Stay Informed: Maintain regular communication with your attorney to stay abreast of any developments in your case.
   6. Consider Mediation or Negotiation
      • Alternative Dispute Resolution: Sometimes, disputes can be settled through mediation or negotiation without going to court, which may expedite the compensation process.
   7. Prepare for Possible Litigation
      • Court Proceedings: If a settlement is not reached, be prepared to go to court. Your attorney will guide you through this process.
   8. Report to Regulatory Authorities
      • Inform the FDA: In addition to legal proceedings, consider reporting the incident to the FDA or other relevant regulatory bodies to contribute to ongoing safety monitoring.

Compensation claims involving medical devices can be complex and require specialized legal knowledge. Engaging a professional with experience in this field can make the process more manageable. The recall of the Cardiosave Hybrid and Rescue IABPs illustrates the importance of prompt action and thorough documentation in such cases. Remember, each case is unique, and the guidance of a legal professional is crucial to navigating the specific legal landscape in your jurisdiction.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like the recalled Cardiosave Hybrid and Rescue Intra Heart Balloon device. 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).