FDA calls for a withdrawal of nearly 8,000 Impella blood pumps due to potential harm or fatality among TAVR patients.
The United States Food and Drug Administration (FDA) has confirmed that Abiomed is taking back its entire batch of left-sided Impella blood pumps. This falls under the category of a Class I recall, indicating that the usage of these apparatuses “may cause serious injuries or death.”
The devices, however, do not necessitate a physical return; the recall has been activated to enhance the consumers’ understanding of the matter.
Abiomed’s withdrawal encompasses 7,895 blood pumps that have been shipped from May 2021 to date. The specific products affected by this recall are the Impella 5.0 Blood Pump, Impella CP Blood Pump, Impella 2.5 Blood Pump, Impella CP with SmartAssist Blood Pump, Impella LD Blood Pump and Impella 5.5 with SmartAssist Blood Pump. The product identification numbers can be found on the FDA’s official website.
These appliances are being withdrawn due to possible complications that might arise if they are implanted into a patient who has previously undergone transcatheter aortic valve replacement (TAVR). Abiomed states that the guidelines of the blood pumps “do not adequately address” the safety measures that should be observed when treating patients who have experienced TAVR, leading to a potential risk of the pump’s motor interacting with the TAVR valve. This interaction might inflict harm or potentially shatter the motor’s blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient,” reads the advisory. “This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.”
There have already been 30 incident reports, including 26 injury cases and four fatalities.
In cases where a medical device like an Impella blood pump has been recalled due to significant health risks, potential lawsuits would typically follow a specific process:
- Engagement of Legal Counsel: The first step in any lawsuit process is to engage legal counsel. Those affected or their families should seek the advice of a lawyer, preferably one who specializes in product liability or medical malpractice cases. The lawyer will review the facts and determine whether there’s a viable case.
- Investigation: If the attorney believes there is a case, an in-depth investigation will be conducted. This may involve gathering medical records, interviewing the patient and their healthcare providers, and reviewing any relevant FDA reports or manufacturer’s information. In this situation, the attorney would likely look into whether the patient was adequately warned about the risks of using the Impella blood pump.
- Filing of Lawsuit: If the lawyer believes there’s sufficient evidence to proceed, a lawsuit will be filed against the responsible parties. This could be Abiomed, the manufacturer of the Impella blood pumps, or other parties involved in the distribution and usage of the product.
- Discovery: Once the lawsuit has been filed, both sides will enter the discovery phase. This involves the exchange of all relevant information and documentation between the plaintiff and the defendant.
- Negotiations or Trial: After the discovery process, the case may be settled through negotiation, or it may go to trial. A settlement can involve the defendant agreeing to pay a certain amount of money to the plaintiff without admitting guilt. If a settlement cannot be reached, the case will proceed to trial where a judge or jury will make the final decision.
It’s important to note that legal procedures can be complex and time-consuming, often taking several years to reach a conclusion. Additionally, the specifics of the process can vary based on the jurisdiction in which the lawsuit is filed and the specifics of the individual case.
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