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Table Of Contents
- Impella Heart Pump Lawsuit Overview
- Latest Impella Heart Pump Lawsuit Updates
- FDA Reports and Statistics
- Impella Heart Pump Injuries & Side Effects
- Do You Qualify for an Impella Heart Pump Lawsuit?
- Impella Heart Pump Information
- Statute of Limitations for Impella Heart Pump Lawsuits
- FAQs
- 1. How do I know if I was injured by the Impella heart pump?
- 2. Can I sue for improper implantation of the Impella heart pump?
- 3. What evidence is needed to support a claim in the Impella heart pump lawsuit?
- 4. What is the Impella heart pump used for?
- 5. How many people have been injured by Impella heart pumps?
- 6. Has Abiomed issued any recalls for Impella devices?
- 7. What is causing the injuries with Impella heart pumps?
- 8. What did the FDA say about “operator handling”?
- 9. When was the Impella heart pump first identified as dangerous?
- 10. Does the FDA require the Impella heart pump to be removed from the market?
- Get Your Free Impella Heart Pump Lawsuit Evaluation With Our Lawyers
Impella Heart Pump Lawsuit Overview
The U.S. Food and Drug Administration (FDA) is warning that left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed have been linked to over 100 serious injuries, including nearly 50 deaths.
The FDA has issued its highest-level alert for the heart pump due to a risk of heart perforation “due to operator handling.”
The Abiomed Impella heart pump recall, categorized as a Class I recall, was initiated on June 14, 2023, encompassing over 7,895 units of the pump distributed from May 1, 2021 [1].
According to a 2022 research by the Medical News, the Impella Heart Pump is marketed as a minimally invasive solution that healthcare professionals can deploy without resorting to heart surgery [2].
The pump is designed to maintain optimal blood flow in patients suffering from coronary artery disease (CAD), recuperating from cardiogenic shock, or awaiting heart transplantation.
Doctors call the Impella a percutaneous ventricular assist device. It keeps the heart working in two situations: during percutaneous coronary interventions (PCI) and following cardiogenic shock. Cardiogenic shock is a life threatening event when the heart cannot pump enough blood to the body.- University of Iowa Heart and Vascular Center.
Latest Impella Heart Pump Lawsuit Updates
- March 21, 2024 – According to an FDA warning published on this date, a slew of recent studies have raised concerns regarding the safety of Impella heart devices, indicating an elevated risk of mortality among patients with unstable medical conditions [3].
- June 14, 2023 – Recall of Abiomed’s Impella left-sided blood pumps initiated, with ongoing lawsuits from affected patients and their families.
- October 2021 – Since Abiomed’s initial acknowledgment of Impella Heart Pump complications, the FDA has received an additional 21 reports detailing heart-wall tears associated with patient fatalities.
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. During operations, the Impella device could cut through the wall of the left ventricle. 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. There have been 129 reported serious injuries, including 49 reports of death.- U.S. Food and Drug Administration (FDA).
FDA Reports and Statistics
The FDA has issued serious warnings about Impella heart pumps:
- The agency is warning about left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed.
- The devices have been linked to over 100 serious injuries, including nearly 50 deaths.
- FDA issued its highest-level alert for the product that poses the potential for death or serious injury.
- According to FDA records, “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”.
- There have been 129 reported serious injuries, including 49 reports of death.
- Presently, there are approximately 66,000 Impella pumps in circulation within the United States, with an additional 26,000 devices deployed across various countries [4].
FDA Issues Highest-Level Alert for Heart Pump Linked to 49 Deaths: TODAY News Video
Impella Heart Pump Injuries & Side Effects
The Impella heart pump has been associated with several severe complications:
- Heart Perforation: Tearing of the heart wall during device insertion or use.
- Left Ventricle Perforation: Specific damage to the left ventricle of the heart.
- Free Wall Rupture: Complete rupture of the heart wall, a life-threatening emergency.
- Hypertension: Abnormally high blood pressure resulting from device complications.
- Lack of Blood Flow: Insufficient circulation potentially leading to organ damage.
- Death: Fatal outcomes have been reported in numerous cases.
Do You Qualify for an Impella Heart Pump Lawsuit?
You may qualify for an Impella Heart Pump lawsuit if:
- You or a loved one underwent a procedure involving an Impella heart pump.
- The patient experienced complications such as heart perforation, left ventricle damage, or death.
- The device was used between May 2021 and the present.
- You can document the connection between the heart pump use and subsequent medical issues.
- You have medical records showing the implantation and any resulting complications.
Key criteria for filing a lawsuit may include:
- Undergoing heart valve replacement surgery wherein the doctor reported pump failure or damage during the procedure.
- Suffering from brain damage or another serious injury due to lack of blood flow, or experiencing the loss of a loved one.
- Undergoing an operation during a heart attack or cardiogenic shock that involved the use of a temporary blood pump.
Evidence Required for an Impella Heart Pump Lawsuit
To support your claim, you will need:
- Medical records documenting the implantation of the Impella device
- Documentation of complications following the procedure
- Expert testimony about the device’s malfunction or risks
- Evidence linking your injury or a loved one’s death to the Impella heart pump
- Any communications with healthcare providers regarding complications
Damages You Can Recover
Compensation in an Impella Heart Pump lawsuit may include:
- Medical expenses for additional treatments or surgeries
- Costs for ongoing care or rehabilitation
- Lost wages due to inability to work
- Pain and suffering compensation
- In wrongful death cases, funeral expenses and loss of companionship
- Punitive damages against the manufacturer in cases of gross negligence
The pumps are temporary implants, tailored to the right or left heart chamber with different levels of pumping power. They are often used after a patient has had a major heart attack and the heart loses its ability to move blood through the body. The devices tend to be used on very ill patients, many with a mortality risk of about 40 to 50 percent. – Dr. Boback Ziaeian, Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA in the Division of Cardiology.
Impella Heart Pump Information
The Impella Heart Pump is marketed as a minimally invasive solution that healthcare professionals can deploy without resorting to heart surgery.
The pump is designed to maintain optimal blood flow in patients suffering from coronary artery disease (CAD), recuperating from cardiogenic shock, or awaiting heart transplantation.
Recall information:
- Recall Date: June 14, 2023
- Classification: Class I (the most serious type of recall)
- Affected Products: Abiomed’s Impella left-sided blood pumps
- Units Recalled: Over 7,895 units distributed from May 1, 2021
- Recall Timeline:
- June 29, 2023: Recall of the Impella RP Flex with SmartAssist, distributed from November 1, 2022, onwards
- June 14, 2023: Recall of Abiomed’s Impella left-sided blood pumps
- April 17, 2023: Recall of Impella 5.5 with SmartAssist devices distributed between September 26, 2021, and March 8, 2023
Statute of Limitations for Impella Heart Pump Lawsuits
The time to file an Impella Heart Pump lawsuit varies by state but typically ranges from 1-3 years from the date of injury or discovery of the injury.
These deadlines are strict, and failing to file within the applicable timeframe can result in losing your right to seek compensation. Contact a wrongful death attorney immediately to ensure your claim is filed within the required timeframe.
FAQs
1. How do I know if I was injured by the Impella heart pump?
If you experienced complications such as internal bleeding, organ damage, blood clots, or other injuries after receiving the Impella heart pump, you may have been injured by the device. Seek medical attention and consult with a lawyer to explore your legal options.
2. Can I sue for improper implantation of the Impella heart pump?
Yes, if the Impella heart pump was improperly implanted or if the surgeon’s negligence contributed to your injury, you may be able to file a medical malpractice lawsuit in addition to a product liability claim against the manufacturer.
3. What evidence is needed to support a claim in the Impella heart pump lawsuit?
To support a claim, you may need medical records documenting the implantation and complications, expert testimony about the device’s malfunction or risks, and any evidence linking your injury or death to the Impella heart pump.
4. What is the Impella heart pump used for?
The Impella heart pump is designed to maintain optimal blood flow in patients suffering from coronary artery disease, recovering from cardiogenic shock, or awaiting heart transplantation. It’s a minimally invasive alternative to traditional heart surgery.
5. How many people have been injured by Impella heart pumps?
According to FDA records, there have been 129 reported serious injuries, including 49 reports of death associated with the use of affected Impella pumps.
6. Has Abiomed issued any recalls for Impella devices?
Yes, Abiomed has issued multiple recalls, including a Class I recall initiated on June 14, 2023, for left-sided blood pumps, and earlier recalls for the Impella RP Flex with SmartAssist and Impella 5.5 with SmartAssist devices.
7. What is causing the injuries with Impella heart pumps?
According to the FDA, the pump catheter may perforate the wall of the left ventricle in the heart. During operations, the device could cut through the wall of the left ventricle, leading to severe complications.
8. What did the FDA say about “operator handling”?
According to the New York Times, the company has attributed incidents of heart-wall tears to “operator handling,” emphasizing the importance of utilizing imaging tools alongside the device to mitigate the risk of puncturing delicate heart tissue.
9. When was the Impella heart pump first identified as dangerous?
Issues with the Impella heart pump were initially identified in January 2018, but Abiomed reportedly only published information about heart-wall perforations as a “rare complication” in October 2021.
10. Does the FDA require the Impella heart pump to be removed from the market?
No, according to the FDA recall notification’s instructions for customers, the pump is “not being removed from the field and does not need to be returned.” However, the alert still permits the continued use of the device with updated risk information.
See all related medical device lawsuits our attorneys covered so far.
Get Your Free Impella Heart Pump Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for injuries related to the Impella Heart Pump. Most states impose strict statutes of limitation on product liability claims, typically ranging from 1-3 years from the date of injury.
Our services include:
- Free, confidential consultations
- No upfront costs or fees
- Payment only if we win your case
The Medical Device Litigation Group at Schmidt & Clark, LLP is an experienced team of trial lawyers that focus on the legal representation of plaintiffs in Impella Heart Pump lawsuits.
We are handling cases nationwide and currently represent clients with Impella Heart Pump injuries in all 50 states.
Don’t wait until it’s too late to seek the compensation you deserve for injuries caused by defective Impella heart pumps.
Free Confidential Case Evaluation: Again, if you or a loved one was harmed by an Impella Heart Pump, you should contact our law firm immediately. You may be entitled to financial compensation by filing an Impella Heart Pump lawsuit and our lawyers can help.
References:
- https://www.nytimes.com/2024/03/29/health/fda-heart-pump-fatalities.html
- https://www.medicalnewstoday.com/articles/impella-heart-pump
- https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks?utm_medium=email&utm_source=govdelivery
- https://www.nytimes.com/2024/03/29/health/fda-heart-pump-fatalities.html