The medical device attorneys at KBD litigate and try medical device cases involving medical device recalls. One type of medical device case KBD Attorneys investigates are heart devices like the Impella and Defibtech devices. We are handling Impella recall and RMU recall matters.
Heart Pump Attorneys – Legal Support for Heart Device Recall and Defect Cases (Impella, Heartmate, RMU)
Seeking justice for injuries caused by defective heart devices? Our experienced personal injury attorneys litigate medical device cases. We fight to ensure you get the compensation you deserve.
There are several heart related devices that are in the news right now. Several heart device failures garner media attention including Defibtech and Impella. These are emerging cases.
For example, we have worked with families already concerning the Impella device. After death of a patient with an Impella heart device, families turn to us for help. As people learn more about HeartMate and Defibtech, we expect more calls like with Impella. Contact us for a free consultation if you had an Impella device or other heart-related device that failed.
Legal Assistance for Recalled Heart Devices, Including Defibtech RMU, Heartmate, and the Impella Device
Heart devices like the Impella heart pump are complex products. FDA approves these products after testing and other regulatory checks. They can provide life-sustaining assistance.
Unfortunately, these heart pumps fail at times. FDA announces recalls of heart devices like the Impella recall. Our legal team provides representation for individuals affected by defective or recalled heart-related medical devices. Our team understands the complexity of medical product cases and is here to help you navigate the challenges of seeking compensation.
Understanding Heart Device Recalls Including Impella and RMU
Heart devices, such as pacemakers, stents, and defibrillators, are critical for patients with cardiovascular issues. However, when these devices fail due to design flaws, manufacturing errors, inadequate labeling, or other defects, the consequences can be severe. Our attorneys handle cases involving:
- Pacemaker failures and complications
- Defective heart valves
- Recalled cardiovascular stents
- Issues with implantable cardioverter defibrillators (ICDs)
- Heart pumps
The Impella Recall Timeline
The Impella heart pump, developed by Abiomed, is a mechanical circulatory support device designed to assist patients with severe heart conditions. Despite its innovative approach, the device has encountered several challenges over the years.
Timeline of Impella Device Issues:
- December 2022: The FDA issued an update regarding the Impella RP System, highlighting post-approval study results and updated labeling to better reflect patient selection criteria.
- May 2023: Impella Recall – Abiomed recalled specific Impella 5.5 with SmartAssist devices due to purge fluid leaks that could cause pump stoppage and loss of support.
- June 2023: Impella Recall – Abiomed recalled the labeling for Impella RP Flex with SmartAssist because the instructions did not adequately address precautions for patients with anticoagulation clotting times below the recommended value, posing a risk of blood clots.
- June 2023: Impella Recall – Abiomed recalled all Impella Left Sided Blood Pumps due to the risk of motor damage after contact with transcatheter aortic valve replacement (TAVR) stents.
- September 2023: The FDA issued a warning letter to Abiomed, citing violations related to the Impella Connect System, including the lack of an approved premarket approval application.
- December 2023: Impella Recall – Abiomed recalled the instructions for use for Impella Left Sided Blood Pumps due to risks of perforation, where the pump catheter could cut through the wall of the left ventricle.
- May 2024: Abiomed removed certain Impella CP with SmartAssist systems from the market due to failed quality inspections, which could lead to unexpected pump stops or release of potentially harmful particulates.
These events highlight the importance of continuous monitoring and prompt action to address medical device safety concerns.
How We Can Help
Our medical device attorneys litigate complex cases like Impella recall lawsuit. They have the expertise to deal with complicated legal issues like preemption, which will be a bar to recovery for injuries from an Impella recall device. They have deposed corporate officers, tried cases against medical devices companies, litigated against the companies involved in the Impella matter, and countless other experiences that position them to help your family through this difficult time. Most importantly, they work directly with individual clients to provide compassionate client-centered care.
Our approach combines thorough investigation with expert medical consultations to build a compelling case on your behalf. We offer:
- Free Initial Consultation: Discuss your case with no upfront cost.
- No Fee Unless We Win: You won’t pay unless we secure compensation for you. We front the expenses and recover them if we recover money for you.
- Experience in Complex Medical Device case:
Current Cases under Investigation
- The Impella Heart Pump (see links about the Impella device below). We have written about the Impella device multiple times as follows.
- The HeartMate II (manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories)
- The HeartMate 3 (manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories)
Check out Some of KBA’s coverage of the Impella device:
FDA Announces Major Recall of Impella Heart Pumps for High Injury Risk
Check out KBA’s coverage of the HeartMate devices:
New Heart Tech
BiVACOR has successfully implanted the first fully mechanical heart into a human patient. The BiVACOR TAH uses an electro-mechanical rotary blood pump. This new device has the potential to change the lives of people waiting for heart transplants. We will keep an eye on this new device to see if there are any issues reported to the FDA.
Start Your Claim Today
Don’t wait to claim the compensation you deserve for injuries caused by defective heart devices. There are important deadlines that apply to these cases. Contact us today.