Abiomed Updates Impella RP Flex with SmartAssist Catheter Labels Due to Risk of Severe Injuries or Fatalities
The U.S. Food and Drug Administration (FDA) has warned that Abiomed is making voluntary modifications to the labeling of its Impella RP Flex with SmartAssist catheter.
This action is not a directive to withdraw the product from circulation but is nonetheless classified as a Class I recall. In this category, the FDA warns that utilization of these devices could result in “severe injuries or fatalities.”
Initially approved by the FDA in October 2022, the Impella RP Flex with SmartAssist is designed to treat acute right-sided heart failure for a duration of up to two weeks. The device is inserted into the patient’s internal jugular vein with the aid of an 11-French indwelling catheter.
The catheter’s label is being revised because its current Instructions for Use (IFU) needs to adequately guide healthcare professionals on the necessary safety measures when a patient’s anticoagulation clotting time is below the advised level. Abiomed has distributed a comprehensive set of guidelines to all its clients to mitigate the risk of blood clot formation. Moreover, the company is updating its IFU to include more specific risk factors and preventive measures for future use.
How to File Your Abiomed Impella RP Flex with SmartAssist Catheter Claim
If you’ve experienced issues with Abiomed’s Impella RP Flex with SmartAssist catheter, you may be considering legal recourse. Below is a guide to help you initiate a claim:
Gather Relevant Documentation
Compile all necessary documents that can help substantiate your claim. These could include medical records, invoices for the medical device, correspondence with healthcare providers, and any adverse incident reports related to the device.
Consult Our Firm
Seek legal advice from one of our medical device claim attorneys. Share the collected documentation and discuss the specifics of your case. An experienced lawyer can assess the strength of your claim and guide you through the legal process.
Determine the Type of Claim
Based on your situation and the advice of your attorney, determine the most appropriate type of claim to file. This could range from a product liability claim to a personal injury lawsuit or even joining an existing class-action if one is available.
File the Initial Complaint
If advised to proceed, your attorney will help you draft and file a formal complaint in the relevant court. This document will outline your allegations, the legal justification for the claim, and the compensation you are seeking.
Begin in Pre-trial Activities
Once the complaint is filed, the discovery phase begins, during which both parties exchange information and evidence. Pre-trial motions may be submitted, and expert witnesses may be consulted. Your attorney might negotiate a settlement during this phase based on the strength of the evidence.
Go to Trial (if necessary)
If no settlement is reached, the case will move to trial. Here, both parties will present their arguments and evidence before a judge or jury. Following deliberation, a verdict will be delivered, which could include financial compensation if you win.
File an Appeal (if necessary)
If the trial outcome is unfavorable, discuss with your attorney whether an appeal is advisable. Appeals can be a lengthy process and are not guaranteed to overturn the original decision.
Receive Settlement or Compensation
If your claim is successful, the final step is to receive the awarded compensation, which may be provided either as a lump-sum payment or through a structured settlement plan over time.
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