For Patients (and Their Families) That Experienced Complications From Catheter-Based Heart Pumps...

Popular Catheter Heart Pump ABIOMED® IMPELLA™ Label Recalled Due to Injuries & Deaths

From the desk of:
Andy Bederman, Managing Attorney

To Affected Patients & Families:

If you (or a loved one) suffered serious complications or a tragic loss after a cardiac procedure involving a temporary catheter-based heart pump, then this may be the most important message you will ever read...

Here is why...

The FDA recently alerted patients and doctors of a serious label recall related to the Abiomed® Impella™ cardiac pump device.

This small, catheter-based pump is inserted into the heart to help maintain blood flow during high-risk cardiac procedures or in cases of acute heart failure.

While meant to provide crucial support, it is alleged that insufficient instructions for use may have put countless patients at risk.

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Deadly Perforation Risk:
When the Impella™ Turns Lethal

One of the most devastating complications linked to the Impella™ is perforation of the heart wall. This occurs when the pump's rigid tube, called a cannula, is inserted into the heart and accidentally punctures the delicate heart tissue.

This puncture can cause potentially fatal bleeding and a life-threatening condition known as cardiac tamponade, where blood fills the space between the heart and its outer lining, preventing the heart from pumping properly.

Shockingly, reports of Impella™-related perforations date back to at least 2016, with numerous case studies detailing catastrophic injuries and deaths from this complication.

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Alarming Study Findings:
Impella's™ Grim Safety Record Exposed

A 2022 study in the Journal of the American Medical Association (JAMA) further sounded the alarm on potential Impella™ safety concerns.

Analyzing over 48,000 patients, researchers found that Impella™ use was associated with significantly higher rates of in-hospital death, bleeding, and stroke compared to alternative balloon pumps.

The authors concluded that more robust evidence was needed to justify Impella's™ widespread use given these concerning outcomes.

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Malfunctions and Failures:
When Your Life-Saving Device Stops Working

Equally troubling are reports of Impella™ devices failing or shutting down unexpectedly during use, leaving vulnerable patients without critical circulatory support.

A 2023 analysis in Circulation®, a leading heart journal, identified an "unacceptable rate" of Impella™ malfunctions and argued that Abiomed® had failed to adequately address these life-threatening reliability issues.

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FDA Uncovers Pattern of Neglect:
Abiomed's® Failure to Prioritize Safety

Despite mounting safety questions, Abiomed's® response has been potentially sluggish and insufficient.

FDA inspection reports reveal a pattern of under-reporting adverse events, inadequate quality control, and failure to promptly conduct critical safety studies.

In a scathing 2023 warning letter, the FDA admonished Abiomed® for these lapses and for repeatedly attempting to shift blame to user error rather than confront potential device defects.

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Not the First Time:
Abiomed's® History of Impella™ Recalls

Shockingly, this isn't the first time Abiomed® has come under fire for Impella™ safety issues.

In 2021 and 2022, the company initiated two other Class I recalls, the most serious type, for Impella™ defects that risked patient harm and death. One recall involved a valve problem that could cause uncontrolled bleeding, while another addressed dangerous electrical failures.

These recurring safety issues paint a troubling picture of a manufacturer potentially failing to learn from past missteps.

The 2024 Impella™ Label Recall:
FDA's Drastic Action Underscores Severity

Now, in 2024, the FDA has once again slapped Abiomed® with a Class I label recall of Impella™ instructions for use due to the heart perforation risk and escalating patient injuries.

This drastic move underscores the severity and urgency of the problem.

For the patients and families who have already suffered devastating complications, the label recall is a bitter validation of their painful experiences.

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What Your Next Step Should Be If You (Or A Loved One) Suffered Complications From An ABIOMED® IMPELLA™ Heart Pump...

Our legal team has closely followed the FDA's label recall and warnings about the Abiomed® Impella™, as well as the growing body of research alleging safety risks with this device.

We are offering free legal consultations and case evaluations to patients who received an Abiomed® Impella™ catheter-based heart pump and experienced any of the following complications, or to family members of patients who tragically passed away after Impella™ treatment:

• Heart wall perforations, tears or rupture
• Uncontrolled bleeding
• Stroke or blood clots
• Device failure or malfunction
• Unexpected death after Impella™ treatment

If you believe you or a loved one may have been harmed by an Impella™ device and would like to learn more about your legal rights, this is your opportunity to speak with an Impella™ lawsuit attorney at no cost or obligation, whether you are the injured victim or a family member.

Act Now - Your Time to File an Impella™ Lawsuit May Be Limited

It's important to understand that the window to pursue legal action for defective medical device injuries is not open-ended. Every state has a "statute of limitations" that sets a deadline for filing lawsuits, both for injury claims and wrongful death cases.

That's why it's so crucial not to delay in speaking with an attorney if you suspect an Impella™ related injury, whether you are the affected patient or have lost a loved one due to an Impella™ complication. Waiting could mean losing your right to pursue an Abiomed® Impella™ lawsuit or settlement forever.

Getting started is simple and easy...

Here is how to get started:

Fill out the free consultation form below and one of our attorneys will promptly call you to discuss your case.

This consultation is FREE. There is no-risk and no obligation. This is simply your opportunity to understand if you have a case and discover what your legal options are in terms of pursuing financial compensation.

And know this...

If at any point you do not believe we are the right fit for helping you get the compensation you rightfully deserve, you are not obligated in any way, shape or form to pay us or work with us. This is a NO-PRESSURE consultation.

We are confident you will see the extraordinary value we can offer you. Our law firm works strictly on a contingency basis -- meaning clients we represent only pay out of their recovery if they win their case.

So act now and fill out the contact form at the bottom of the page. Or simply pick up the phone and call us right now at 844-722-4984.

We stand ready to help you win your case.

Sincerely,

Andy Bederman
Owner & Managing Attorney
Law Offices of Greenberg & Bederman, LLC