Abiomed Impella Blood Pump Lawsuit

Abiomed Impella Blood Pumps were recalled after 49 people died and 129 people suffered severe heart injuries when the device punctured their heart.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Abiomed Impella Blood Pump induced injury cases in all 50 states. If you or somebody you know was injured or died of a heart problem from an Abiomed Impella Blood Pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

49 People Died When Blood Pump Punctured Heart

Even a slight mistake during the operation to implant an Impella Blood Pump can be deadly. Tragically, 49 patients died when the tip of the pump catheter punctured a hole in their heart, and many other people were seriously injured.

129 Patients Severely Injured By Impella Blood Pumps

At least 129 patients have been severely injured by an Abiomed Impella Blood Pump. The life-threatening risks include:

• Pump catheter cuts a hole in the heart
• Heart puncture or perforation
• Heart laceration
• Partial-tear in the wall of the left ventricle
• Severe internal bleeding
• Heart failure
• Loss of blood-flow
• Patient must undergo emergency open-heart surgery
• Free wall rupture
• Hypertension (severe high blood pressure)
• Death

What is a Blood Pump?

A blood pump is a medical device that doctors use in emergency situations when a patient’s heart is unable to pump enough blood to the body. Patients may receive a blood pump in the first 48 hours after a major heart attack, during open-heart surgery, or if they have a heart problem called cardiomyopathy.

What is the Impella Left-Sided Blood Pump?

The Impella Left-Sided Blood Pump is a type of heart pump, also called a Left Ventricular Assist Device (LVAD). It is implanted inside the left ventricle, which is the heart’s main pumping chamber. The Impella device is manufactured by Abiomed, a medical device manufacturer that was acquired by Johnson & Johnson in 2022.

What Does It Look Like?

The Impella Blood Pump consists of a long, straw-like tube called a catheter. Inside the catheter is a tiny but powerful pump. The pump goes inside the patient’s heart. It is not a permanent implant. Instead, it is used to temporarily reduce the workload on the heart until it can heal, and then the pump is removed.

What Happens During Blood Pump Surgery?

Not surprisingly, it is an extremely delicate operation to implant an Impella Blood Pump inside the heart, especially for patients who are already in critical condition after a heart attack, or severely ill due to a heart problem.

Surgeons must cut an incision in the patient’s groin or chest area to gain access to the major blood vessels, then carefully thread the Impella Blood Pump through the blood vessels to get to the heart. Then the surgeon must push the Impella Blood Pump through the heart valve into the correct position in the left ventricle.

What is the Left Ventricle?

The heart has four chambers, and the left ventricle is the heart’s main pumping chamber. It is surrounded by thick, powerful muscles because it must supply blood to the entire body. Any injury to the left ventricle is life-threatening.

What Causes Heart Perforations?

Heart perforations may occur when a surgeon accidentally hits the wall of the left ventricle with the tip of the pump’s catheter. It may also occur in patients with high-risk conditions, or during active cardiopulmonary resuscitation (CPR), according to Abiomed.

Blood Pump Catheter Can Puncture Heart

The tip of the Impella Blood Pump’s straw-like catheter is not sharp, but surgeons must be careful not to push it too far inside the patient’s heart. With enough force, it can cut the wall of the left ventricle, or completely puncture the heart muscle.

Even Slight Mistakes Can Be Life-Threatening

Abiomed claimed that Impella Blood Pumps were “safe and effective,” even as the company received dozens of reports from surgeons who had problems implanting the device safely and said their patients died or were severely injured.

Are Impella Blood Pumps Safe?

Abiomed advertises the Impella Blood Pump as a breakthrough life-saving device. It is “The World’s Smallest Blood Pump” for surgeons to use in emergency situations. Since it hit the market 2020, over 66,000 Impella Blood Pumps have been sold to U.S. hospitals nationwide.

Abiomed Updates Instructions For Use With New Warnings

Abiomed recalled Impella Blood Pumps in December 2023, but they were not pulled off the market. Doctors still use this device. The only change is that Abiomed has updated the Instructions For Use to emphasize the importance of carefully positioning the pump catheter to avoid puncturing the heart.

Abiomed Asks Surgeons To Be More Careful

Abiomed began receiving reports of patient injuries and deaths very soon after the Impella Blood Pump was approved in 2020.

In October 2021, Abiomed urged surgeons to be more careful and sent out a “Technical Bulletin” with updated instructions on proper placement of the catheter during the implantation procedure to avoid heart perforations.

Unfortunately, despite sending out the Technical Bulletin, Abiomed continued receiving reports of patient deaths and injuries due to heart perforations over the next two years. In December 2023, two months after receiving an FDA Warning Letter, Abiomed finally agreed to recall about 66,000 Impella Blood Pumps.

FDA Warning Letter for Impella Blood Pumps

Abiomed did not immediately notify the FDA about the safety hazards outlined in the Technical Bulletin from October 2021. In September 2023, the FDA sent Abiomed a Warning Letter after FDA officials determined that the Technical Bulletin was actually a “Medical Device Correction” that should have been reported to the FDA.

FDA Announces Class 1 Recall for Impella Blood Pumps

In March 2024, the FDA announced a Class 1 recall for about 66,390 Abiomed Impella Left-Sided Blood Pumps due to the risk of severe injury or death.

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.”

How To Identify Recalled Abiomed Impella Blood Pumps

In December 2023, Abiomed recalled Impella Blood Pumps to update the Instructions For Use (IFU) on how to reduce the risk of heart perforations.

In March 2024, the FDA upgraded this action to a Class 1 recall. This is the most serious type of recall, reserved for medical devices with a serious safety hazard that is linked to severe injuries or deaths.

The recall involves the following Impella Left-Sided Blood Pumps:

• Impella 2.5
• Impella CP
• Impella CP with SmartAssist
• Impella 5.0
• Impella 5.5 with SmartAssist
• Impella LD
• Distribution Dates: October 10, 2021 to October 10, 2023
• Approximately 66,390 Impella Blood Pump devices were recalled in the U.S.
• Product Codes: See Recall Database Entry

What Should Doctors Do?

In December 2023, Abiomed sent an “Urgent Medical Device Correction” letter, asking doctors to adhere to the following 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 cardiopulmonary resuscitation
• Review the updated warnings in the device Instructions For Use (IFU)
• 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 (IFU)

Do I have an Abiomed Impella Blood Pump Lawsuit?

The Schmidt Firm, PLLC is currently accepting Abiomed Impella Blood Pump induced injury cases in all 50 states. If you or somebody you know suffered a heart perforation or other injury when a doctor tried to implant an Impella Left-Sided Blood Pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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