Abiomed Impella Heart Pumps: Are You Eligible for Compensation?

FDA Issues Warning About Abiomed Impella Heart Pump

The FDA has announced that Abiomed has recalled the instructions for Impella left-sided blood pumps. The FDA has identified this as a Class I recall, the most serious type of recall, indicating that the situation involves serious injuries or death.

According to the FDA, Abiomed is recalling its pumps because the pump catheter may cut through the wall of the left ventricle and possibly other heart structures. This can have serious medical consequences, including damage to the heart, hypertension, lack of blood flow, and death.

As of March 21, 2024, FDA reports that there have been 129 reported serious injuries, including 49 reports of death.

HeartMate II and HeartMate 3 Recall

Abbott/Thoratec Corp. has issued a recall for its HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to a serious issue known as Extrinsic Outflow Graft Obstruction (EOGO). This condition occurs when biological material accumulates between the HeartMate Outflow Graft and the Outflow Graft Bend relief or other components added during surgery, potentially obstructing the device and reducing its effectiveness in aiding the heart to pump blood.

The recall, classified as a Class I recall by the FDA—the most serious type—indicates that the use of these devices may cause serious injuries or death. The recall affects 13,883 devices distributed in the U.S. since April 21, 2008, and was initiated by the firm on February 19, 2024.The HeartMate II and HeartMate 3 LVAS are critical devices used to support patients with severe left ventricular heart failure, either as a bridge to heart transplantation, to aid in heart recovery, or as a long-term solution when transplantation is not an option.

The HeartMate 3 is also approved for use in pediatric patients. In response to the recall, Thoratec Corporation sent an Urgent Medical Device Correction Letter to all affected customers, requesting them to complete and return an acknowledgment form. Healthcare professionals and patients using these devices are advised to be aware of the recall and follow the instructions provided in the correction letter.

Who May Be Eligible for Compensation Due to Impella Heart Pumps

If you or a loved one had a temporary blood pump inserted during a serious cardiac event like a heart attack, then suffered injury afterward, an Impella heart pump may have been at fault. Some of the reported outcomes of an improper implantation are:

• heart perforation
• fluid or blood around the heart
• emergency surgery for something other than the original condition
• critically low blood pressure or critically fast heart rate
• death

Typically, these events would have taken place within 24 hours of the heart pump implantation.

Note that the statute of limitations may prevent some claims. Please start the free case evaluation process as soon as possible if you suspect that you or a loved one may have been injured by an Abiomed Impella device.

How CCK Can Help You Secure Compensation

If you or a loved one suffered injury because of an Impella heart pump, you may qualify for compensation. Chisholm Chisholm & Kilpatrick LTD and Levin Papantonio Rafferty are working to get victims the compensation they deserve.  Fill out the form on this page to see if you qualify or call us today at (844) 755-7899.