Abiomed Announces Voluntary Recall to Revise Labeling Instructions for Its Impella RP Flex with SmartAssist, Citing Concerns About Blood Clot Formation.
The U.S. Food and Drug Administration (FDA) has designated a Class I recall for Abiomed’s Impella RP Flex with SmartAssist device. This is the most severe type of recall, indicating that use of the device could result in severe health complications or even death.
It’s essential to note that this is a voluntary labeling correction, rather than a complete withdrawal of the product from the market.
About the Device
The Impella RP Flex with SmartAssist Catheter is specifically designed for temporary use, up to two weeks, in patients suffering from acute right heart failure following the implantation of a left ventricular assist device. The catheter is inserted through the internal jugular vein and aids the heart’s right ventricle by directing blood into the pulmonary artery.
Why the Recall?
The reason behind the recall is a deficiency in the catheter’s Instructions for Use (IFU). The existing guidelines do not adequately inform healthcare providers about the precautions needed when treating patients whose anticoagulation clotting time falls below the advised timeframe. Individuals with systemic anticoagulation levels below the recommended 160-180 seconds, particularly those with central venous lines and cardiac cannulas, are at heightened risk.
Though healthcare providers can continue to use these devices, there’s an increased risk of severe adverse outcomes, including the potential for blood clot formation. So far, 12 injuries have been reported, though no deaths have been linked to this issue.
Who is at Risk?
- Patients receiving circulatory support from Impella RP Flex with SmartAssist
- Healthcare workers attending to patients using this specific device
On June 29, 2023, Abiomed disseminated an Important Medical Device Advisory letter to all its clients. The company suggests maintaining systemic anticoagulation within the advised ACT range of 160-180 seconds when indwelling central lines are in place. Healthcare providers should also assess the risk of thrombus formation on pre-existing lines before initiating support.
For further guidance, Abiomed directs healthcare providers to refer to the “best practices pathway” outlined in Figure 5.2 of the IFU. This section has detailed criteria that focus on specific risk factors such as:
- Evidence of end-organ failure
- Active infection indicators
- Documented Deep Vein Thrombosis (DVT)
- Patients on right-sided support or ECMO
Abiomed plans to revise the IFU for the Impella RP Flex with SmartAssist to more clearly delineate the risks and recommendations concerning thrombus formation.
For any questions regarding this recall, customers are advised to contact Abiomed’s Clinical Support Center.
Healthcare professionals and consumers may also report any adverse reactions or quality issues to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program via online forms, regular mail, or fax.
How to Determine If You Have a Valid Claim for Compensation
If you or a loved one have been adversely affected by a medical device, medication, or any other product, you may be wondering how to establish whether you have a valid claim for compensation. Here are some general guidelines to help you evaluate your situation:
- Establish the Injury or Harm: The first step in any compensation claim is to ascertain that actual harm or injury has occurred. This could be physical harm, emotional distress, or financial loss.
- Link the Injury to the Product: You must be able to show a direct connection between your injury and the use or exposure to the defective product. Medical records, incident reports, and expert testimony can help establish this link.
- Determine the Type of Liability: There are generally three types of product liability claims:
- Manufacturing Defects: These are flaws that occur during the production of the item.
- Design Defects: These are intrinsic flaws in the design of the product itself.
- Failure to Warn: This happens when a company does not provide adequate instructions or warnings about the potential risks of using the product.
- Collect Evidence: To strengthen your claim, gather all related evidence like medical records, bills, photographs of the injury and the defective product, and any correspondence with the manufacturer or healthcare provider.
- Consult a Legal Professional: If you believe you have a claim, consult a lawyer who specializes in product liability cases. They can assess the strength of your claim and guide you through the legal process. Many law firms offer a free initial consultation for this.
- Time Limitations: Be aware that there are statutes of limitations that define how long you have to file a claim. The timeframe can vary depending on the jurisdiction and the nature of the claim.
- File the Claim: If advised by your attorney, proceed to formally file a claim against the liable parties. This could be a lawsuit filed in a court or a claim through an existing settlement fund.
- Negotiate Settlement or Go to Trial: Once the claim is filed, you may either negotiate a settlement or go to trial, depending on what your lawyer advises and how the defendant responds.
- Secure Compensation: If your claim is successful, you could be eligible for compensation for medical bills, lost wages, pain and suffering, and possibly more, depending on the specifics of the case.
By considering these steps, you can better understand whether you may have a valid claim for compensation and how to proceed.
If you or a family member have suffered adverse effects from this faulty product, we invite you to reach out for a complimentary case evaluation. You may be eligible for significant financial compensation to cover medical bills, emotional distress, and other damages. Parker Waichman LLP is a nationally recognized law firm specializing in product liability cases, committed to securing justice and compensation for victims across the United States.
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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