Recall Summary
| Recall number | Z-2457-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | Abiomed, Inc. |
| Units affected | 10 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
The abiomed impella recall is a Class I safety action announced by the U.S. Food and Drug Administration on June 24, 2026. The FDA gave it recall number Z-2457-2026. It involves the Impella CP Set with SmartAssist, a heart pump system made by Abiomed, Inc. A Class I recall is the most serious type. It means the FDA believes the product could cause serious injury or death. This guide explains what happened in plain language. It also explains what the recall does and does not mean for patients and families.
What the Abiomed Impella Recall Covers
The abiomed impella recall covers a specific device. It is the Impella CP Set with SmartAssist. This is a percutaneous heart pump used to support blood circulation. The affected product codes are 1000080, 1000851, 0048-0014, and 0048-0024-JP. These codes help hospitals and clinicians identify the exact units involved. If you are a patient, you likely will not have these codes yourself.
The scope of this recall is small. According to the FDA record, only 10 units are affected. However, a small unit count does not lower the severity. The FDA still classified this as Class I. That classification reflects the potential harm, not the number of units. For example, a device used in critical heart care can carry high risk even in limited quantities.
The recall was posted by the FDA on June 24, 2026. The company named in the record is Abiomed, Inc. The Impella system is used in hospital settings, typically during high-risk procedures or cardiac support. As a result, most affected units are handled by medical professionals, not consumers. Hospitals and clinicians are the primary audience for the official correction instructions.
The Hazard and What Could Go Wrong
The hazard in the abiomed impella recall involves purge pressure. The FDA record describes the problem clearly. Exposure to a low purge pressure occurrence may cause persistent low purge pressure alarms. In some cases, it may lead to interruption or loss of mechanical circulatory support. That support is what keeps blood moving during critical care.
This matters because the device supports the heart. A loss of mechanical circulatory support during a procedure can be dangerous. For example, a patient relying on the pump may face serious risk if support is interrupted. This is why the FDA treats the issue as a Class I event. The alarm itself signals that something needs immediate attention.
It is important to be precise here. The FDA record does not state whether injuries have been reported. As a result, this guide will not claim that injuries occurred. It also will not claim that none occurred. We follow the agency record exactly. Typically, a recall notice describes a potential hazard, not a confirmed count of harm. The table below summarizes the verified agency details.
| Detail | Information |
|---|---|
| Recall Number | Z-2457-2026 |
| Issuing Agency | U.S. Food and Drug Administration |
| Recall Date | June 24, 2026 |
| Company | Abiomed, Inc. |
| Units Affected | 10 units |
| Severity Classification | Class I |
What To Do If You Are Affected by the Abiomed Impella Recall
If the abiomed impella recall affects your care, the most important step is simple. Follow the official instructions. The FDA has posted an official notice for this recall. That notice contains the correction steps for the affected units. Because this is a hospital device, clinicians usually manage the response. Do not attempt to service or adjust the device yourself.
For patients and families, the best action is to ask questions. Contact your treating physician or the hospital that handled your procedure. Ask whether your care involved an affected unit. Provide the product codes listed above if it helps. In most cases, your care team can check device records and answer directly.
The specific remedy for this recall is not restated in this guide. The agency record contained remedy text that did not match the product. As a result, it has been withheld here to avoid giving wrong instructions. Instead, follow the instructions in the official notice linked on this page. That notice is the correct source for the current correction steps.
Keep any paperwork you have. Save procedure records, device information, and hospital communications. These documents can help you confirm details later. However, do not panic. A recall is a structured safety process. Typically, it is designed to correct a problem before wider harm occurs. Staying informed is the most useful thing you can do.
Does a Abiomed Impella Recall Mean You Can Sue?
A recall and a lawsuit are not the same thing. The abiomed impella recall is a safety action taken with the FDA. It is not a court case. It is not a finding of legal fault. It does not promise money to anyone. This is a key point that is often misunderstood. A recall alone is not a legal claim.
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A lawsuit generally requires more than a recall. In most cases, it requires an actual injury. It also requires a link between that injury and the product. Lawyers call this causation. Without both an injury and causation, a recall by itself usually does not support a claim. For example, owning a recalled device with no harm is different from being hurt by one.
If you believe you were harmed, talk to a licensed attorney. A qualified lawyer can review your medical records and the facts. They can explain whether you may be eligible to pursue a claim. Note the careful wording. You may be eligible. No one can promise a specific outcome or payment. Every case depends on its own facts and evidence.
How Recalls Connect to Mass Tort Cases
Recalls and mass tort cases are separate, but they can be linked over time. A recall documents a known safety problem. Later, if many people report similar injuries, lawyers may investigate. As a result, a recall can sometimes become one piece of evidence in later litigation. However, the recall itself does not create a case.
History shows how this can unfold. The Philips CPAP recall of 2021 later led to widespread litigation over breathing machines. The Takata airbag recalls became one of the largest safety events in auto history and drew major legal action. These examples show a pattern. For example, a recall can raise awareness, and injured people may then seek legal advice. Still, each situation is unique, and no outcome is guaranteed.
Frequently Asked Questions
Is the abiomed impella recall a Class I recall?
Yes. The FDA classified it as Class I under recall number Z-2457-2026. Class I is the most serious category. It means the product could cause serious harm.
How many units are affected by the abiomed impella recall?
The FDA record lists 10 units. This is a small scope. However, the severity remains Class I because of the potential hazard involved.
Does this recall mean I have a lawsuit?
No. A recall is a safety action, not a lawsuit. A claim generally requires an injury and a link to the product. Speak with a licensed attorney to learn if you may be eligible.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed July 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.