St. Louis Abiomed Impella Heart Pump Recall Lawyer

Impella Recall Lawyer

Abiomed has initiated a voluntary recall of its Impella left ventricular support devices, which the company said could cause heart perforation or a free wall rupture of the heart. The recall started on December 27, 2023, and was accompanied by updated guidelines for device use.

If you or a loved one received an Abiomed Impella heart pump implant between October 2021 and October 2023, you should speak to an Impella recall lawyer from Burger Law about your eligibility for receiving compensation.

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Gary Burger

Litigation attorney

In its latest warning, the FDA issued an Impella recall of the device’s instructions, which led to concerns that the pump’s catheter may puncture the left ventricular wall of the heart. Therefore, former patients with the implant may have experienced perforation or rupture of the left ventricle, hypertension, or poor blood flow. The use of the device and the accompanying instructions also led to several deaths.

The short-term devices that Abiomed manufactures are designed to support the pumping functions of the left ventricle during high-risk catheter-type procedures, especially percutaneous coronary interventions (PCIs). 

PCIs are usually indicated for patients with anterior myocardial infarction or heart disease. The procedure is frequently performed in women and the elderly.

The catheter is threaded through blood vessels when a patient undergoes complicated surgeries or faces life-threatening cardiac conditions. 

Recalled Impella Models

The Impella blood pumps that have been listed in the latest recall include the 2.5 pump, CP models, 5.0 device, 5.5 with SmartAssist technology, and LD model. As noted, all the devices comprising the recall were distributed between October 10, 2021, and October 10, 2023. The FDA designated each recall of the Impella heart pump as Class I, indicating the highest level of danger. There have been 129 reports of serious injury and 49 deaths associated with this complication since the agency’s last update.

The FDA’s Warning Letter and Findings

The Food and Drug Administration (FDA) issued a notification to Johnson & Johnson’s subsidiary, Abiomed, concerning lapses in the reporting of device defects related to their Impella heart pump as well. They also cited the company for operating a monitoring system without appropriate premarket clearance.

On September 19, 2023, the agency pinpointed several deficiencies in Abiomed’s quality management and device incident reporting practices. These offenses preceded the recall of some Impella 5.5 heart pump units earlier in the year.

In its review, the FDA determined that certain aspects of the Impella monitoring system’s software functions required premarket approval. The warning was publicized on the FDA’s website. Despite these issues, Johnson & Johnson confirmed that the Impella heart pumps were still commercially available and were being actively used in patient care. A company representative asserted via an email that the company was in active dialogue with the FDA to address and rectify any oversights.  

Market and Recall Activities – Warnings and Important Stats

Below are some facts about how the devices were introduced and marketed, along with the impact of several device recalls. Johnson & Johnson acquired Abiomed for $16.6 billion in December 2022, marking the most prominent transaction within the medical technology field for the year 2022. 

Following this acquisition, and as part of its consolidation into its cardiovascular suite, Johnson & Johnson planned to smoothly incorporate Abiomed’s products into its offerings.

Impella’s 5.5 Devices

In tandem, Abiomed’s Impella 5.5 devices were the subject of user reports concerning leaks and mechanical damage – both of which stood to hinder the device’s safety and functioning.

The Impella units were used to support patients after heart attacks during open-heart surgery. They were used in circumstances where the heart’s ability to pump was compromised. The pump was used for conditions such as cardiomyopathy. Their Impella device was used as a short-term mechanical support for the heart.

Following the report of 179 complaints, three injuries, and no fatalities, Abiomed initiated a recall in April 2023 for 466 units of the Impella 5.5 with SmartAssist. 

The company expressed that, despite reports of key problems, they delayed any corrective action or recall until the FDA inspection took place from March 1 to April 13, 2023.

Further Abiomed Oversights

The FDA’s warning highlighted additional concerns, including Abiomed’s failure to submit reports on device malfunctions that ultimately resulted in serious injuries or death. 

In August 2023, Abiomed’s retrospective examination of 254 reports revealed a need for product history reviews on 51 records. According to the FDA, Abiomed’s conclusion that these reviews did not require further action was not supported by the documentation.

Abiomed has since provided comprehensive instructions for the return and replacement of the recalled units. However, they noted that the latest variants of the Impella 5.5 with SmartAssist, featuring new design improvements, were not subject to the recall.

Again, the FDA also criticized the company for its Impella Connect monitoring system, which has been used without the requisite premarket approval or an exemption for investigational devices. The system enables remote tracking of the pump’s operations and alerts users to varying alarm statuses.

In conclusion, the FDA will review the submitted documentation from Abiomed and further decide on the legal marketability of the product.

According to Abiomed, the Impella Connect application, which is also available on the market, does not interfere with the pump’s performance.

Johnson & Johnson emphasized their commitment to complying with the evolving guidelines for the pump’s software device functions while addressing the FDA’s concerns.

What the FDA Warning Did Not Address

The FDA’s current warning does not include a separate recall of Impella products related to incompatibility issues with transcatheter aortic valve replacement stents. This recall involved nearly 7,900 heart pumps in June 2023. These devices, which were associated with four patient deaths, are currently still in use.

Again, all of Abiomed’s Impella devices – used in managing cardiogenic shock and performing heart procedures – were subject to four Class I recalls in 2023, including the most recent recall of the product. 

The Latest Recall of the Product

The latest action involves more than 66,000 units distributed in the US from October 2021 through October 2023. More than 26,000 devices have also been shipped internationally, according to records in the database.

Abiomed’s Revised Guidelines

In revised guidelines for their use issued for healthcare professionals, Abiomed added stronger cautions recommending imaging during catheter advancement or rotation. The company emphasized that special care be taken during catheter insertion into certain patient anatomies or in patients receiving CPR.

A company representative stated that “the updated instructions contain more detailed technical recommendations focused on implantation and adjustment.”

Asked whether Abiomed would consider suspending sales of its pumps due to these concerns, the spokesperson reiterated that “the health notification does not remove Impella devices from the market” and that they’re still available for use.

Legal Actions Taken Against Abiomed on the Use of the Impella Heart Pump

Patients who have suffered severe harm and families mourning the loss of a loved one due to a malfunctioning Impella heart pump have initiated legal actions against the device’s producer, Abiomed. These legal actions are currently in the preliminary phase, while the affected parties seek counsel from personal injury lawyers in the fields of product liability and wrongful death.

The Argument Supporting the Litigation

As of July 2023, the defective Impella heart pump by Abiomed has been linked to four fatalities. The overarching assertion for the ongoing litigation is that the manufacturer and its distributors failed to ensure consumer safety, thus holding them accountable for the damages arising from the faulty medical devices.

As of March 2024, the litigation process has not seen new developments. However, attorneys are still open to taking on additional cases.

How Recalls and Lawsuits Have Unfolded

In June 2023, Abiomed announced a recall spanning Impella blood pump devices distributed from May 1, 2021.

In July 2023, the FDA designated the recall of the Abiomed Impella blood pumps as a Class I recall, which is the most severe classification, citing 30 complaints, 26 injuries, and four deaths.

Previously, in March 2018, Abiomed had agreed to a $3.1 million settlement over assertions that it provided lavish meals for physicians to incentivize the purchase of its pumps.

The latter litigation varies significantly from the 2018 case. While the former allegations concerned unethical activities, the current lawsuits are focused on direct claims of harm. These claims make up personal injury and wrongful death claims due to the product’s noted defects.

In September 2023, patients who had experienced adverse effects from the heart pump or relatives of injured or deceased individuals were reportedly collaborating with legal representatives to pursue claims related to the recalled pumps.

In October 2023, the FDA sent Abiomed a warning letter following an inspection of their Massachusetts production facility. The company’s responses were deemed insufficient. 

During this time, the FDA claimed that Abiomed’s marketing of its Impella Connect system was occurring without necessary premarket approval.

Backtracking to December 2023, ongoing investigations into potential lawsuits were reported with no agreements on global settlements or any trials calendared.

The Main Reasons Impella Heart Pump Lawsuits Are Being Filed

Litigation against Abiomed has emerged from patients and family members of those who have received Impella left-sided blood pumps for transcatheter aortic valve replacement procedures. Plaintiffs suspect that the devices were the cause of severe injuries and fatalities.

The suits allege that Abiomed negligently failed to inform medical professionals about the potential for the pumps to malfunction or break apart during procedures.

The Supporting Evidence and Warnings – Noted By the FDA

“The damaged Impella system might lead to reduced blood flow or complete cessation of the pump, possibly deferring necessary therapy – being insufficient in maintaining patient support. This carries the potential for severe consequences in patients reliant on significant support levels. Additionally, the risk of disintegrated blade fragments entering a patient’s bloodstream exists.”

– The Food & Drug Administration (FDA) 

Impella Product Liability Cases

There have been several actions for product liability due to complications like pump failure with the Impella heart pump, where individuals suffered extreme injuries such as cerebral damage due to impeded blood flow.

In certain cases, patients required cardiac surgery to extract the device or its fragmented components.

The Criteria for Eligibility: You May Be Entitled to Compensation

Eligibility for lawsuit participation includes:

• Having undergone valve replacement surgery where the medical record indicates a pump malfunction or damage therein.
• Experiencing brain damage due to blood flow obstruction or sustaining other severe injuries.
• Experiencing a loved one’s death from the use of the pump.
• Going through a procedure employing a temporary blood pump during a myocardial infarction or cardiogenic shock.

For successful product liability claims related to wrongful death, proof is necessary to establish that the heat pump’s defect, be it through manufacturing, design flaws, or inadequate use instructions, was the cause of the casualty. 

The specific mechanical fault identified in the Abiomed Impella heart pump involved a compromised purge sidearm, escalating the hazard of purge fluid leakage.

The Heart Pump Recall Timeline: Stats and Specific Products

Key moments in the Impella Heart Pump Recalls timeline include:

December 27, 2023: A recall of 66,390 devices (distributed from October 10, 2021 to October 2023) concerned the instructions for using the pumps.

June 29, 2023: The Impella RP Flex featuring SmartAssist, distributed beginning November 1, 2022, was subject to recall.

June 14, 2023: Abiomed announces its recall of Impella left-sided blood pumps, coinciding with individuals and their families filing litigation suits. The recall affected over 7,895 units distributed beginning May 1, 2021.

April 17, 2023: Impella 5.5 with SmartAssist devices distributed from September 28, 2021, through March 6, 2023, became subject to a recall.

Abiomed’s guidelines insisted that physicians avoid using the affected device in procedures unless no alternatives existed, outlining steps for minimizing dangers or death.

Key Steps to Take to Pursue an Abiomed Heart Pump Lawsuit

The initial move towards filing an Impella heart pump lawsuit is to consult with an attorney who is experienced in product liability claims. 

Claims can be made by patients who’ve been injured or by relatives on behalf of a patient who has died or their estate.

Process for Filing an Impella Lawsuit:

• Start by engaging with a knowledgeable product liability attorney.
• Furnish all relevant details and medical records of the patient’s history and event chronology to your legal counsel.
• The law firm will assist in collecting the necessary documentation to assess your case.
• Afterward, the legal team will establish if your case has merit and strategize on the lawsuit filing approach.
• Your attorney will represent your claims and manage all the legal proceedings on your behalf.

What You Can Receive in Damages for an Impella Settlement Claim

A successful lawsuit or settlement is contingent upon the nature and gravity of the injuries sustained. Possible recoveries can include expenses for past and future medical care, loss of earnings, and compensation for physical and emotional suffering. Our Impella recall lawyers can fully assess the quantifiable damages and give you a better idea of what to expect in a settlement.

The goal of this type of lawsuit is to show that the defective medical device led to injury or death. Therefore, your lawyer must demonstrate the manufacturer’s negligence toward patient care and safety. 

Learn More About Your Legal and Financial Rights Today From Our Impella Recall Attorneys

Schedule a consultation with Burger Law in St. Louis if you believe you’re eligible to file an Impella lawsuit. Contact us today for a free consultation with an Impella recall lawyer.

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Gary Burger

Founder | Injury Attorney
Gary Burger has dedicated his career to standing up against bullies. The founder and principal attorney of Burger Law | St. Louis Personal Injury Lawyer has helped hundreds of Missouri and Illinois individuals and families recover th …
Years of experience: 30 years
Location: St. Louis, MO

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