Texas Abiomed Impella Heart Pump Lawyer

Abiomed recalled more than 66,000 Impella Left Sided Blood Pumps after at least 49 people died when a doctor punctured their heart during the implantation operation.

Need a Texas Impella Heart 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 or a loved one was injured or died of complications from an Abiomed Impella Heart Pump, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

Abiomed Recalls Impella Heart Pumps After 49 Deaths, 129 Severe Injuries

In April 2024, the FDA issued a Class 1 recall for more than 66,000 Impella Left Sided Blood Pumps because doctors could cut or puncture a patient’s heart during the operation to implant the device. At least 129 patients were severely injured, including 49 patients who died.

Why Were Impella Heart Pumps Recalled?

Impella Left Sided Blood Pumps look like a sharp straw, which doctors must carefully insert through the major blood vessels of the heart into the left ventricle, which is the heart’s main pumping chamber.

The problem is that the Impella heart pump’s catheter can cut or puncture the wall of the patient’s heart during operations to implant the device. This can cause severe injury, internal bleeding, or death.

The FDA warned about the following life-threatening risks:

“The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”

What is an Impella Left Sided Blood Pump?

Impella Left Sided Blood Pumps, also known as “heart pumps,” are medical devices that are implanted into the left side of a patient’s heart to help move blood out of the left ventricle and into the body.

The device is implanted in patients whose heart is unable to pump enough blood to their body due to an injury or medical condition, such as a recent heart attack, open heart surgery, or a serious heart problem called cardiomyopathy.

Impella Left Sided Blood Pumps help the heart pump blood, which reduces the work-load on the heart. This can help the heart heal and recover, which is especially important after a heart attack or surgery.

What Heart Pumps Were Recalled?

The recall involves several types of Impella Heart Pumps, which are used for different therapeutic purposes. The recall includes 66,390 devices that were distributed in the U.S. from October 2021 through October 2023. The following devices are affected by the recall:

• Impella 2.5
• Impella CP
• Impella CP with SmartAssist
• Impella 5.0
• Impella 5.5 with SmartAssist
• Impella LD

When Did Abiomed Warn Doctors?

Abiomed issued its first warning about the risk of heart perforations from the Impella heart pump in a Technical Bulletin that was sent to customers in October 2021. This warning was not sent to the FDA.

In September 2023, the FDA inspected Abiomed and sent the company a warning letter for various violations of federal law, including failing to disclose reports of heart perforations.

In December 2023, Abiomed responded by sending customers an Urgent Medical Device Correction letter with the following new and revised warnings:

• Carefully position the pump catheter during operative procedures
• Use imaging when advancing or torquing the pump catheter
• Use special care when inserting the pump catheter in patients with certain high risk conditions or during active CPR
• Review the updated warnings in the device Instructions for Use
• Notify everyone at your facility who needs to be informed of this recall correction
• Notify any other facilities where the products have been forwarded of the updated Instructions for Use

Impella Heart Pumps Recalled in July 2023

In June 2023, Abiomed recalled all Impella Left Sided Blood Pumps due to a risk of motor damage after contact with Transcatheter Aortic Valve Replacement (TAVR) Stents.

The contact may damage or destroy the motor’s impeller blades. There is “a risk that pieces of the broken blades could enter the patient’s bloodstream,” according to the recall, as well as other life-threatening injuries. Abiomed reported 26 injuries and 4 deaths related to the issue.

Need an Impella Heart 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.