Texas Abiomed Impella Blood Pump Lawyer

At least 49 people died when an Abiomed Impella Blood Pump device punctured their heart, according to a Class 1 recall.

Need a Texas Abiomed Impella Blood Pump Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured or a loved one died of heart problems from an Abiomed Impella Blood Pump, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

What is the Problem?

The Impella Blood Pump was advertised as a life-saving device, but at least 129 people were seriously injured, including 49 people who died, when the device punctured their heart.

What is the Risk?

Abiomed Impella Blood Pumps have been linked to life-threatening health risks, such as:

• Punctured heart
• Left ventricle perforation (cut a hole in the wall of the left ventricle in the heart)
• Free wall rupture
• Hypertension (severe high blood pressure)
• No blood flow
• Death

Abiomed Knew About Blood Pump Injuries & Deaths For Years Before Recall

Abiomed advertised the Impella Blood Pump as “safe and effective,” but soon after the Impella Blood Pump was approved in 2020, Abiomed began receiving reports of severe injuries or patient deaths.

What Happened?

These tragic injuries and deaths occurred when the tip of the Impella Blood Pump punctured the heart or cut into the wall of the left ventricle, which is the main pumping chamber in the heart. Any type of injury to the left ventricle is life-threatening and often deadly.

What Should Doctors Do?

In October 2021, Abiomed sent doctors a “Technical Bulletin” with updated instructions on how to safely implant the Impella Blood Pump. Abiomed emphasized how important it is to carefully position the pump catheter to avoid accidentally causing a heart perforation.

Abiomed Aware of Blood Pump Problems For Years

Over the next two years, Abiomed continued to receive reports of patient injuries and deaths due to heart perforations and problems inserting the pump catheter safely, despite the Technical Bulletin.

Abiomed Gets FDA Warning Letter

In September 2023, Abiomed received a Warning Letter for failing to notify the FDA of the Technical Bulletin, which the FDA classified as a “Medical Device Correction” because it was intended to prevent injuries and deaths.

Abiomed Recalls Impella Blood Pumps to Update Instructions

Two months after the FDA Warning Letter, Abiomed announced a recall for more than 66,000 Impella Blood Pumps in December 2023. The recall did not pull the devices off the market. Instead, Abiomed used the recall to officially update the Instructions For Use (IFU).

What is the Problem?

Doctors may accidentally cut or puncture the patient’s heart while trying to insert the Impella Blood Pump device, according to the FDA.

There were 129 severe injuries, including 49 deaths reported when an Impella Blood Pump catheter accidentally perforated (cut) into the wall of the patient’s left ventricle during the operation to implant the device.

According to the FDA:

“Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. … Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”

What Causes Heart Perforations?

Heart perforations occur when the Impella Blood Pump’s catheter cuts a hole into the left ventricle wall of the patient’s heart during the operation to implant the pump, according to Abiomed’s recall warning.

Heart perforations can also occur when an Impella Blood Pump is used on patients with certain high-risk conditions, or during active cardiopulmonary resuscitation (CPR), according to Abiomed.

What Is The Impella Blood Pump?

The Impella Blood Pump is a medical device that is manufactured by Abiomed. The straw-like device consists of a long, flexible tube that contains a tiny pump. Doctors must carefully insert the device through the patient’s major blood vessels, into the left ventricle of their heart.

The pump is designed to provide short-term support for the circulatory system so the heart has time to recover. There are several types of Impella Blood Pumps that are used for different therapeutic reasons.

Why Do Doctors Use Impella Blood Pumps?

Impella Left-Sided Blood Pumps are used when the heart is unable to supply enough blood due to a condition called cardiogenic shock. Doctors may implant an Impella Blood Pump in patients who had a severe heart attack within 48 hours, open-heart surgery, or when their heart is not functioning well due to a condition called cardiomyopathy, according to the FDA.

Need an Abiomed Impella Blood Pump Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.