The medical device attorneys at KBD (f/k/a KBA Attorneys) litigate and try medical device cases. One type of medical device case that KBD Attorneys investigates are heart devices like the Impella heart pump and Defibtech RMU chest compression devices.
Many medical device cases arise from medical device recalls. One such recall is the Impella Recall. We are handling several heart-related recall medical device cases, including:
- Impella recall
- Impella RP recall
- Heartmate II and Heartmate 3
- Accolade Pacemaker recall
- RMU recall
- POLARx recall
Heart Pump Attorneys – Legal Support for Heart Device Recall and Defect Cases
Impella Recall, Heartmate II Recall, Heartmate 3 Recall, Accolade Pacemaker, POLARx Recall, RMU Recall
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.
We have worked with families already concerning the Impella heart pump. After death of a patient with an Impella heart device, families turn to us for help. As people learn more about HeartMate, POLARx, and Defibtech, we expect more calls like with Impella.
Contact us for a free consultation if you had an Impella 5.5, other Impella pump model, or other heart-related device that failed.
Legal Assistance for Recalled Heart Devices, Including Defibtech RMU medical device, Heartmate, and the Impella Device
Heart devices like the Impella heart pump are complex products. FDA approves these products after testing and clears some through other regulatory checks. Learn more about the pathway to market here. They can provide life-sustaining assistance.
Unfortunately, these heart pumps fail at times. FDA announces recalls of heart devices like the Impella recall and the Accolade recall. Our legal team provides representation for individuals affected by defective or recalled heart-related medical devices. A special brand of product liability lawyers, our medical device attorneys understand the complexity of medical product cases and is here to help you navigate the challenges of seeking compensation.
Understanding Heart Device Recalls Including Impella Recall and RMU Recall
Heart devices, such as pacemakers, stents, and defibrillators, may be 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 including the FDA Impella Recall:
- 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.
- February 2025: Impella RP recall announced.
These events highlight some of the events related to the Impella pump and some Abiomed Impella heart pump recall. Healthcare professionals need to be aware of these recalls and patients should discuss them with their doctors if they had any of these products.
The Impella recall may lead to and interesting Impella Lawsuit
A prior Impella lawsuit alleged off-label marketing. A lawsuit from 2014 alleged that, “Abiomed engaged in a scheme to market the Impella 2.5, a percutaneous micro heart pump that provides circulatory support, for purposes that had not been approved by the United States Food and Drug Administration and made misleading statements….” This was a securities related class action case. The suit claimed Impella was a main source of revenue for the company. This is the Impella 2.5, not the Impella 5.5. Nonetheless, this is smoke plaintiffs’ lawyers investigate. We’d expect investigation into the marketing practices concerning the Impella heart pump devices at issue in the Impella recall discussed herein.
In another abiomed lawsuit, more recently in an action for patent infringement, a company Maquet Cardiovascular LLC battled with Abiomed. Maquet owns six patents concerning “guidable intravascular blood pumps and related methods” while Abiomed, Inc. and other Abiomed-named entities manufacture the “Impella” line of “intravascular blood pumps.” As noted by the Court in a filing there, Abiomed started marketing Impella in 2008. At issue include models related to recall Impella recalls including. the Impella 2.5, Impella 5.0, Impella CP, and Impella RP. The patent dispute includes the Impella CP with SmartAssist, which comes up in a recent Impella RP recall.
Medical device attorneys like us may look to the patent related documents to understand the design and function of the Impella heart device. This can be a rich source of evidence for product related problems.
The RMU medical device and the RMU recall – a chest compression device that stopped working
FDA cleared the RMU medical device in October 2021. It went through the 510(k) process. Therefore, we do not anticipate preemption and other legal complexities being at issue. The FDA details are here https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211289
See the FDA clearance letter here:
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211289.pdf
After just a few years, we saw the RMU recall. The firm notified users in July 2024, just months before its three year anniversary. The RMU recall issue concerned a significant, life-threatening hazard. Specifically, a problem in the device’s motor could cause the device to stop compressions. “This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.”
How We Can Help
Our medical device attorneys litigate complex cases like the Impella 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 Heart Device Cases KBA is Investigating
KBA is looking at several heart-related medical devices. There has been an uptick in heart device recalls. We have investigated several of them. Our focus right now is on the following heart related devices:
- 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)
- Defibtech RMU recall (RMU chest compression)
- Boston Scientific Accolade Pacemaker recall: Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude Pacemaker recall
- The Boston Scientific Recall: The PolarX recall and the PolarX FIT recall
Boston Scientific Recall:
A study of the longevity of a pacemaker noted that “Each year a growing number of Americans has a pacemaker implanted or replaced. In 1995 the number of implantations broke 600 per million people in the population, reaching 604 per 1,000,000 people. Of these implantations, 20% were replacements.” In 2024, we noted a recall of a Boston Scientific Pacemaker.
1. Accolade Pacemaker Recall: Accolade Recall, Proponent Recall, Essentio Recall, Altrua Recall, Visionist Recall, and Valitude Pacemaker Recall
Boston Scientific Accolade is a heart-related medical device. The Accolade pacemaker helps the heart beat. A Boston scientific recall in 2024 raises concern after two deaths and 832 injuries.
The Accoladae recall concerns several models int he Accolade pacemaker family. These Accolade devices subject to the Accolade recall are:
- ACCOLADE™;
- PROPONENT™;
- ESSENTIO™;
- and ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and
- VISIONIST™; and
- VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Due to a manufacturing issue, the battery may not last as long as it should. It may underpower the heart device. As a result, the pacemaker may not do what it’s supposed to; it may not regular the heart properly.
See more here:
Accolade Pacemaker: Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude Pacemaker Recall
The Accolade Pacemaker recall comes after two deaths. See more here:
A recall concerning the battery life of a pacemaker is pretty serious. You may have wondered, what is the longest someone has lived with a pacemaker? An article from 2022 noted someone had continuous cardiac pacing for 53 years. Another study found a median survival of about 8.5 years.
We did an analysis of some adverse event reports submitted to FDA. Check it out here.
2. Boston Scientific Smartfreeze Cryo Console: POLARx and POLARx FIT Cryoablation Catheter
Check out Some of KBA’s Coverage of the Impella Device, the Impella Recall:
FDA Announces Major Recall of the Impella Heart Pump for High Injury Risk
Check out KBA’s coverage of the HeartMate devices:
HeartMate II Recall and Heartmate 3 Recall – Heartmate Injury and Heartmate Death
New Heart Tech
We don’t just write about when things go wrong. Eternal optimists and tech enthusiasts, we watch for industry trends and developments.
We recently learned that BiVACOR 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
In the meanwhile there are heart-related devices with serious recalls out there. If you had an Impella heart pump, an Accolade pacemaker, RMU chest compression device, POLARx, Heartmate II, or Heartmate 3 and suffered an injury, contact us.
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 by the form on this page, calling us at 855-KBA-LAWS (522-5297), or by email, Intake@KBAattorneys.com.
