Recall Summary
| Recall number | Z-2238-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-03 |
| Company | Abiomed, Inc. |
| Units affected | 625 |
| 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 notices reached hospitals across the country in June 2026. The U.S. Food and Drug Administration classified this action as Class I. That is the agency’s most serious recall category. The recall involves the Automated Impella Controller, or AIC, made by Abiomed, Inc. This device runs heart pumps used during high-risk cardiac procedures. The recall number is Z-2238-2026, dated June 3, 2026. In total, 625 units are affected. If you or a family member had an Impella heart pump procedure, this notice may matter to you.
What the Abiomed Automated Recall Covers
The abiomed automated recall covers the Automated Impella Controller. The AIC is the bedside console that drives an Impella heart pump. It is not the pump itself. Instead, it is the control unit that monitors and powers the pump. Clinicians rely on it during and after cardiac procedures.
The FDA record lists several packaged controller configurations by product code. These include Impella Controller, Packaged, CA, under product code 0042-0000-CA. The record also lists Impella Controller, Packaged, EU, under product code 0042-0000-EU. A third listed configuration is Impella Controller, Packaged, UK, under product code 0042. The agency record is truncated at that point.
The scope is 625 units. For example, that figure represents consoles distributed under the identified product codes. The agency record does not spell out full distribution dates in the entry summarized here. As a result, patients should not assume a specific purchase window. Hospitals and cath labs are the typical purchasers of this equipment, not individuals.
Typically, patients never see the controller’s product code. The device sits in a hospital, not a home. However, the abiomed automated recall still affects patient care directly. A console problem during a procedure can affect how the heart pump performs. That is why the FDA treats this as a serious matter.
The Hazard and Reported Injuries
The FDA record describes this as a retrospective submission covering identified issues. The first group of issues involves the consoles themselves. Certain AIC consoles showed alarm failures. They also showed power-path faults and electrical-short risks. In addition, inaccurate motor-current sensing was identified.
The second issue involves alignment inside the device. There is improper alignment between the purge cassette and the motor drive in the AIC. This misalignment can cause a piston block event. As a result, the purge system may fail to complete priming. In that situation, the user must switch to a backup AIC console.
These are meaningful problems in a critical-care setting. For example, an alarm that fails to sound may delay a clinical response. Inaccurate motor-current sensing can obscure how the pump is actually performing. A failure to prime the purge system interrupts setup at a time when speed matters. However, the agency record does not state whether any injuries have been reported in connection with this recall. Do not assume harm occurred, and do not assume it did not.
Class I is the FDA’s highest severity classification. In most cases, that label signals a reasonable probability of serious injury or death if the problem is not corrected. It reflects the potential risk, not a count of confirmed harm. The table below summarizes the core agency data.
| Recall number | Z-2238-2026 |
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 3, 2026 |
| Company | Abiomed, Inc. |
| Product | Automated Impella Controller (AIC) |
| Units affected | 625 |
| Severity classification | Class I |
What To Do If You Own This Product
Most readers do not own an AIC console personally. This is hospital equipment. However, if you manage or operate this device in a clinical setting, act on the recall notice now. Identify affected units by product code. The listed codes include 0042-0000-CA and 0042-0000-EU.
The official notice contains the instructions you should follow. We are not stating a specific remedy here. The agency record’s remedy text does not match this product, so it has been withheld. Instead, follow the instructions in the official notice linked on this page. Contact Abiomed directly if the notice is unclear.
Facilities should also confirm that a backup console is available and functioning. The hazard description specifically references switching to a backup AIC console. For example, a piston block event during priming may force that switch without warning. Typically, preparedness planning is part of a facility’s recall response.
If you were a patient, your steps look different. Start by requesting your procedure records from the hospital. Ask whether an Impella heart pump and AIC console were used. Then ask your treating physician whether the recalled equipment was involved in your care. However, do not stop any prescribed treatment based on a news article. Talk to your doctor first about any medical concern.
Does a Abiomed Automated Recall Mean You Can Sue?
A recall is not a lawsuit. That distinction matters, so we will say it plainly. The abiomed automated recall is a safety action. It is a regulatory step taken to correct or remove a product from use. It is not a court finding, and it is not an admission of legal fault.
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As a result, the existence of a recall alone does not create a legal claim. In most cases, a product liability claim requires more than a recall notice. You typically need an actual injury. You also need a causal link between the defect and that injury. Documentation, medical records, and device identification usually matter a great deal.
We are not aware of verified litigation specific to this recall, and we are not asserting that any exists. Nothing here should be read as a claim that a case has been filed. However, if you believe you were harmed during a procedure involving this equipment, you may be eligible to pursue a claim. That determination is not something an article can make.
Speak with a licensed attorney in your state. An attorney can review your medical records and the device details. They can also explain deadlines, which vary by state and can be short. No outcome is guaranteed, and no one can promise compensation. Be cautious of anyone who does.
How Recalls Connect to Mass Tort Cases
Recalls and mass torts are separate things that sometimes intersect. A recall notice creates a documented record. It records what the manufacturer identified, when, and how the agency classified the risk. In later litigation, plaintiffs’ attorneys often use those records as evidence. For example, they may point to the timeline between an internal finding and a public notice.
History offers real examples of this pattern. Philips recalled millions of CPAP and BiPAP devices starting in 2021 over foam degradation concerns. That recall was followed by consolidated federal litigation. Takata airbag inflators were recalled at enormous scale over rupture risk, and extensive litigation followed. However, neither example predicts anything about the abiomed automated recall. Each case turns on its own facts, its own science, and its own proof.
Frequently Asked Questions
What exactly was recalled in the abiomed automated recall?
The FDA recall covers the Automated Impella Controller, or AIC, from Abiomed, Inc. Listed configurations include packaged controllers under product codes 0042-0000-CA and 0042-0000-EU. The recall number is Z-2238-2026, and 625 units are affected.
Why is this recall labeled Class I?
Class I is the FDA’s most serious recall classification. It generally signals a reasonable probability that use of the product could cause serious injury or death. It reflects potential risk, not a tally of confirmed injuries.
Does the abiomed automated recall mean I have a legal case?
No. A recall is a safety action, not a lawsuit or a finding of liability. If you were injured during a procedure involving this equipment, you may be eligible to pursue a claim, and a licensed attorney can evaluate your specific 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 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.