Recall Summary
| Recall number | Z-3148-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-23 |
| Company | Abiomed, Inc. |
| Units affected | 5,232 |
| 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
abiomed automated recall records show that the U.S. Food and Drug Administration posted a Class I device recall on September 23, 2026. The recall covers the Automated Impella Controller, also called the AIC. Abiomed, Inc. makes this controller. It runs the Impella heart pump, which supports blood flow in critically ill patients. The FDA lists 5,232 units in scope. The problem involves a part inside the purge pressure sensor assembly. Class I is the agency’s most serious recall category.
What the Abiomed Automated Recall Covers
The abiomed automated recall covers the Automated Impella Controller. The FDA record lists several packaged versions of the controller. Each version has its own product code. The record includes these entries:
- Impella Controller, Packaged, CA (Product Code: 0042-0000-CA)
- Impella Controller, Packaged, EU (Product Code: 0042-0000-EU)
- Impella Controller, Packaged, IN (Product Code: 0042-0000-IN)
The agency record lists more entries after these three. As a result, check the full product list in the official notice. Lot numbers and serial numbers were not part of the summary data we reviewed. Typically, the official notice or the company’s letter to customers has those details.
The product codes end in different regional suffixes. However, the FDA record does not explain what each suffix means. In most cases, regional codes show where a unit was packaged or labeled. We will not guess beyond that. A hospital’s biomedical engineering team can confirm which codes it uses.
This is not a consumer product sold in stores. Typically, the AIC is used in cardiac catheterization labs, operating rooms, and intensive care units. Patients do not buy it themselves. However, patients and families still have good reason to follow the abiomed automated recall. It involves equipment that may be part of their care.
The Hazard and Reported Injuries
The FDA describes the hazard this way: “the potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.” Put simply, the controller may fail to recognize the purge cassette. The cause is a failing part inside a sensor assembly.
Why does this matter? The Impella pump relies on a purge system. Typically, this system pushes fluid through the pump to help protect its motor. The controller manages that purge. If the controller cannot recognize the cassette, the purge may not work as intended. The FDA summary does not describe every possible outcome. For that reason, clinicians should read the full notice.
The Class I label is significant. The FDA uses it when there is a reasonable probability that a product will cause serious adverse health consequences or death. That is the agency’s general definition. It is not a finding that harm has occurred in this case. However, it shows how seriously the FDA views the abiomed automated recall.
The agency record does not say whether any injuries or deaths have been reported. We will not claim either way. For example, the FDA’s adverse event database may show reports over time. Those reports are not proof of cause, though. Check the official notice for the latest information.
| Detail | Information |
|---|---|
| Recall number | Z-3148-2026 |
| Issuing agency | U.S. Food and Drug Administration |
| Date | September 23, 2026 |
| Company | Abiomed, Inc. |
| Product | Automated Impella Controller (AIC) |
| Units affected | 5,232 |
| Severity | Class I |
What To Do If You Own This Product
In most cases, the “owners” in this abiomed automated recall are hospitals and health systems. The most important step is simple. Follow the instructions in the official notice. The agency record we received had remedy text that did not match this product. As a result, we have left the remedy out of this guide. Please do not rely on secondhand summaries.
Start by identifying affected units. Check each controller’s label for its product code. Compare it with the full list in the official notice. Then match serial numbers against any company letter you received. Typically, biomedical engineering or clinical engineering staff handle this task.
Patients have a different role. If you or a loved one is on Impella support, you are under active medical care. Do not try to adjust or inspect the device. Instead, ask the care team whether the recall affects your equipment. For example, you might ask, “Was this controller checked for the September 2026 recall?”
Keep records if you had problems after Impella treatment. Request copies of your medical records. Write down dates, symptoms, and what your doctors told you. You can also report problems through the FDA MedWatch reporting program. For full recall instructions, read the official FDA recall notice.
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Does a Abiomed Automated Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. A company corrects or removes a product, and the FDA classifies and oversees that action. The abiomed automated recall alone does not create a legal claim. It also does not mean anyone is owed money.
A legal claim typically needs more than a recall. In most cases, a person must show a real injury. They must also show that the product likely caused that injury. Medical records, device records, and expert opinions often matter. Without injury and causation, a recall usually cannot support a case on its own.
Medical device cases can also face extra legal hurdles. For example, in Riegel v. Medtronic (2008), the Supreme Court limited certain state-law claims. That case involved devices approved through the FDA’s premarket approval process. However, a lawyer can explain whether such rules apply to a given device. This is one reason to get professional advice.
As of October 1, 2026, we have not verified any lawsuit tied to the abiomed automated recall. If you believe you were harmed, speak with a licensed attorney in your state. You may be eligible to file a claim, depending on your facts. Deadlines called statutes of limitations apply. No outcome is guaranteed.
How Recalls Connect to Mass Tort Cases
A recall can later become evidence in court. For example, Philips recalled millions of CPAP and ventilator devices in June 2021. The concern was sound-dampening foam that could break down. Lawsuits followed and were combined in federal court in Pittsburgh. In 2024, Philips agreed to pay $1.1 billion to resolve personal injury claims. In that litigation, recall documents helped show what the company knew and when.
Takata airbags offer another example. Defective inflators led to the largest auto recall in U.S. history. Takata pleaded guilty in 2017 and agreed to a $1 billion criminal penalty. However, most recalls never lead to mass tort litigation. The abiomed automated recall is, for now, a safety action. Whether it ever plays a role in litigation depends on future facts.
Frequently Asked Questions
What product is part of the abiomed automated recall?
The recall covers the Automated Impella Controller, made by Abiomed, Inc. Listed product codes include 0042-0000-CA, 0042-0000-EU, and 0042-0000-IN. Additional codes appear in the official FDA notice.
Have injuries been reported?
The agency record does not state whether injuries have been reported. We do not claim either way. Check the official FDA notice for updates.
Can I get compensation because of this recall?
A recall by itself is not a legal claim. If you were injured and the device may have caused it, you may be eligible to pursue a claim. A licensed attorney can review your situation.
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 October 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.