When a medical device meant to support a failing heart instead causes catastrophic injury or death, the questions that follow are both urgent and complex.
The Impella heart pump, a temporary mechanical device used in critically ill cardiac patients, has been the subject of multiple serious FDA safety actions, including a Class I recall tied to left ventricular wall perforation.
Dozens of deaths and hundreds of serious injuries have been reported to the FDA in connection with Impella devices and related components.
For families who have lost a loved one, or patients who suffered a cardiac perforation, major bleeding, or another life-threatening complication during Impella use, understanding what happened and who may bear legal responsibility can be overwhelming.
Prior results do not guarantee a similar outcome.
What Is the Impella Heart Pump?
The Impella is a percutaneous ventricular assist device, or pVAD. Unlike traditional heart surgery, it’s inserted through a catheter in the groin or arm and threaded into the heart.
Once positioned across the aortic valve, this small axial-flow pump withdraws blood from the left ventricle and moves it into the aorta, doing some of the heart’s pumping work while the heart muscle recovers or while doctors perform a high-risk procedure.
Cardiologists generally use Impella in two situations:
Complex, high-risk coronary interventions (sometimes called CHIP procedures), where a patient’s heart is weak enough, or their blockages severe enough, that opening the arteries could cause the heart to fail during the procedure itself.
Cardiogenic shock, a life-threatening condition where the heart suddenly can’t pump enough blood to sustain the body’s organs, often following a major heart attack.
Medical literature describes Impella as potentially life-saving in carefully selected patients, capable of maintaining blood pressure, reducing strain on a failing heart, and buying time for recovery or a bridge to more permanent treatment.
Why Did the FDA Issue a Class I Recall for Impella Devices?
On March 21, 2024, the FDA announced a Class I recall, its most serious category, for Impella left-sided blood pumps. The recall was triggered by reports that the pump catheter had perforated the wall of the left ventricle, the heart’s main pumping chamber.
When that happens, blood can leak into the sac surrounding the heart, a condition called hemopericardium, compressing the heart and preventing it from filling properly. Without emergency intervention, this can be fatal within minutes to hours.
A few key facts about this recall:
It covered approximately 66,390 devices distributed between October 2021 and October 2023, including the Impella 2.5, CP, CP with SmartAssist, 5.0, 5.5 with SmartAssist, and LD models.
As of the recall, the manufacturer, Abiomed (now part of Johnson & Johnson MedTech), had reported 129 serious injuries and 49 deaths associated with left ventricular perforation.
The recall was technically a correction, meaning updated instructions and warnings rather than removing devices from the market.
The FDA noted that Abiomed had posted information about the perforation risk on its own website back in October 2021, roughly two years before formally notifying the FDA, which delayed the warning that ultimately reached doctors and hospitals.
That last point matters for legal claims. A Class I recall is powerful evidence that the FDA concluded the device posed a foreseeable, serious risk, and a documented delay in notifying regulators speaks directly to whether warnings reached physicians and patients in time.
What Other Impella Safety Problems Have Emerged?
The 2024 perforation recall wasn’t an isolated event. In the years since, the FDA has issued a series of additional safety actions covering the Impella platform, including:
February 2025 (correction letter sent December 2024): Updated instructions for the Impella RP with SmartAssist and RP Flex with SmartAssist after Abiomed identified a risk that guidewires or other devices could contact the pump during insertion or removal, potentially damaging an optical sensor and causing a temporary or permanent pump stop.
February 2026: A correction addressing a differential pressure sensor in Impella RP devices that could drift over time and display inaccurate readings, associated with 22 reported serious injuries as of mid-January 2026, along with a separate, smaller correction the same month involving first-generation purge cassettes prone to leaking, associated with 4 reported serious injuries and no deaths at the time.
June 2026: A correction for introducer kits, manufactured by Oscor for Abiomed/J&J MedTech, used to insert the Impella catheter through the femoral artery. The FDA identified manufacturing issues causing certain 14 French and 23 French sheaths to leak from the sidearm, sheath cap, or hub area. Because Impella patients are routinely anticoagulated to prevent clotting on the device, undetected bleeding from a leaking introducer can escalate quickly.
As of April 2026, the manufacturer had reported eight instances of major bleeding and three associated patient deaths, though the company disputed that the deaths were caused by the introducer defect. The FDA has not independently resolved that causation question, leaving it open to expert dispute.
August 2026: An early alert covering all Automated Impella Controllers (AICs), the external console that runs the pump, due to a purge cassette recognition failure that can delay or interrupt circulatory support.
As of mid-August 2026, the manufacturer had reported 37 serious injuries and three deaths tied to this issue.
This list isn’t exhaustive. Abiomed and J&J MedTech have issued numerous additional corrections and early alerts on Impella controllers and components since 2023, reflecting an ongoing pattern of manufacturing and design issues on the platform beyond the pump catheter itself.
What Does Medical Research Say About Impella Risks?
Independent of the recalls, published research has raised broader questions about Impella’s risk-benefit profile. The DanGer Shock trial, an international randomized trial published in the New England Journal of Medicine in 2024, found that adding Impella CP to standard care in heart attack patients with cardiogenic shock reduced 180-day mortality (45.8% versus 58.5%, roughly a 13-point absolute reduction).
That benefit came with a real cost: a composite safety outcome covering severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic valve leakage occurred in 24.0% of the Impella group versus 6.2% of the standard-care group, a roughly four-fold increase.
These results describe a specific patient population, STEMI patients with cardiogenic shock, and shouldn’t be assumed to apply the same way to every Impella model or every high-risk PCI patient.
These reports are useful for spotting potential safety signals, and they’re part of what regulators and plaintiffs’ experts review, but a MAUDE report is a description of a suspected problem, not a confirmed finding.
Can You Sue for Impella Perforation, Injury, or Death?
Yes. When an Impella device or related component causes cardiac perforation, major bleeding, loss of circulatory support, or death, patients and families may have grounds for legal claims. These generally fall into two categories.
Medical malpractice, against the physicians and hospitals involved in care, can include:
Negligent patient selection, using Impella in someone who wasn’t a good candidate or where safer alternatives existed
Improper insertion or positioning, including inadequate imaging guidance or failure to follow FDA-recommended precautions
Inadequate monitoring, such as failing to recognize placement signal changes, alarms, or signs of perforation
Delayed recognition or treatment of complications like cardiac tamponade, limb ischemia, or major bleeding
Failure to obtain informed consent. If a physician didn’t disclose the FDA recalls, the known perforation risk, the reported deaths, or the available alternatives, the patient or family may not have been able to make a truly informed decision. A Class I recall tied to dozens of deaths is the kind of risk New York law requires doctors to disclose.
Product liability, against the device manufacturer, generally focuses on:
Design defect claims, arguing the catheter’s configuration creates an unreasonable risk of contact with the ventricular wall or other devices, and that a safer alternative design was feasible
Manufacturing defect claims, pointing to specific production issues like the introducer kit leakage or purge cassette failures as evidence of defects introduced during manufacturing
Failure to warn claims, alleging the manufacturer didn’t timely update warnings and instructions after learning about post-market safety issues, or didn’t adequately communicate those risks to physicians and hospitals
These claims can seek damages for wrongful death, pain and suffering, medical expenses, and, for a surviving spouse, loss of consortium.
How Do FDA Recalls Affect a Legal Claim?
A Class I recall isn’t legally binding in civil court, but it’s meaningful evidence. When the FDA concludes that a product’s use could cause serious injury or death, that reflects the agency’s review of adverse event data, manufacturer reports, and scientific literature, and it signals that the risk was foreseeable and serious.
Plaintiffs can point to recall notices, safety alerts, and adverse event counts, like the 129 injuries and 49 deaths tied to perforation, or the injuries and deaths tied to the introducer and controller issues, to show that a given injury isn’t an isolated incident.
That said, a recall doesn’t decide an individual case by itself. Courts and juries still hear expert testimony on causation, including whether a particular patient’s death is attributable to the device, physician decisions, the patient’s underlying disease, or some combination, and defendants often argue that a critically ill patient’s death or injury was inevitable regardless of the device.
Proving that the device or negligent care was a substantial factor in the harm, even against that backdrop, is the central task in these cases.
What Evidence Is Needed to Build a Case?
Building an Impella case requires reconstructing what happened both medically and mechanically. Useful records generally include:
Catheterization lab and procedure notes documenting access site, sheath size, device insertion and removal times, and any access-site complications
Device records, including the Impella model and serial number, controller logs showing alarms or errors, pump settings, and total support duration
ICU and nursing flowsheets tracking hemodynamic trends, vascular checks, bleeding assessments, and lab results for coagulation, hemolysis, and kidney function
Imaging and operative reports documenting pericardial effusion or tamponade, vascular injury, or ventricular perforation
Hospital device and recall records showing whether staff were aware of the relevant recall or safety alert at the time of treatment
The autopsy or medical examiner report, if a death occurred
Expert testimony is essential, generally including a cardiology or cardiac surgery expert on the standard of care and how the complication occurred, a biomedical engineering expert on device design and manufacturing, and, in a death case, a forensic pathology expert on cause of death.
Who Can Bring a Claim and What Damages Are Available in New York?
Under New York’s wrongful death statute, only the personal representative of the deceased’s estate can bring a wrongful death claim, suing on behalf of the surviving spouse, children, parents, or other distributees.
Damages can include the economic value of the support and services the deceased would have provided, medical and funeral expenses, and loss of inheritance. New York also allows a separate survival claim for the conscious pain and suffering the person experienced between injury and death.
For patients who survive an Impella-related complication, a personal injury claim can seek compensation for past and future medical expenses, lost wages and earning capacity, and pain and suffering.
A spouse may also have a derivative claim for loss of consortium.
Because many Impella patients are critically ill going into the procedure, defendants often argue that a poor outcome was inevitable regardless of the device or the care provided.
Overcoming that defense generally requires expert testimony establishing that the device or negligence was a substantial factor in the harm, even against a difficult underlying prognosis.
How Long Do You Have to File a Claim in New York?
Medical malpractice. Generally two years and six months from the act, omission, or end of continuous treatment for the same condition, under CPLR 214-a.
Wrongful death. Generally two years from the date of death, under EPTL 5-4.1.
Product liability. Generally three years from the date of injury, under CPLR 214(5).
Public hospitals. If the treatment happened at a public hospital, such as an NYC Health + Hospitals facility, a notice of claim is generally required within 90 days of the incident, well before the underlying deadline above would otherwise run. Missing that 90-day window can bar an otherwise valid claim.
For families dealing with a sudden loss, or patients recovering from a serious complication, the early months are often consumed by grief and medical bills, but the deadlines don’t pause for that. Talking with an attorney as soon as possible is the best way to protect your options.
Frequently Asked Questions
Does the FDA recall automatically mean I have a case?
Not automatically. A Class I recall is strong evidence that the FDA found the device could cause serious injury or death, but you’d still need to show that the recalled defect actually affected your device or situation, and that it caused your or your loved one’s injury or death. An attorney can help evaluate whether your specific facts connect to the recalled issue.
My family member was very sick before the Impella procedure. Do we still have a claim?
Possibly. Insurers and manufacturers often argue that a critically ill patient’s death was inevitable, but that argument isn’t automatically true, and it doesn’t end the inquiry. If the device malfunctioned or the care fell below the standard expected, and that contributed to the outcome, a claim may still be viable even against a difficult underlying prognosis. This is a fact-specific question best evaluated with your medical records.
Can we sue both the hospital and the device manufacturer?
Yes, in some cases. If a device defect and negligent care both contributed to the same injury, both a product liability claim and a medical malpractice claim may apply. They have different deadlines and different proof requirements, so it’s worth having an attorney evaluate both.
What if my loved one’s death certificate doesn’t mention the Impella device?
A death certificate isn’t the final word on cause of death. Courts allow parties to present qualified expert evidence challenging an official death narrative, particularly when device malfunction or complications like tamponade or hemorrhage aren’t reflected in the initial paperwork. Full medical records and expert review, not just the certificate, generally drive causation in these cases.
How soon should I talk to an attorney?
As soon as possible. New York’s deadlines are strict, especially the two-and-a-half-year window for malpractice claims, and important evidence like device logs and hospital recall records can become harder to obtain the longer you wait. A consultation can clarify your options even if you haven’t decided whether to move forward.
Summing It Up
When a device meant to support the heart instead causes catastrophic harm, understanding whether the device, the care, or both fell short generally requires a careful review of the medical records alongside qualified experts. If you or a loved one has been affected, that review is the clearest way to understand your options.
Porter Law Group represents New York families in medical malpractice, catastrophic injury, and wrongful death cases, including those involving defective medical devices.
If you or a loved one has been affected by an Impella-related injury or death, call 833-PORTER9, email info@porterlawteam.com, or reach us through our contact page for a free, confidential consultation. Prior results do not guarantee a similar outcome.
This article is for informational and educational purposes only. It is not a substitute for medical advice from a qualified healthcare provider or legal advice based on your specific circumstances.
