Recall Summary
| Recall number | Z-2601-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-07-01 |
| Company | Abiomed, Inc. |
| Units affected | 168 |
| 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
An abiomed impella recall was announced by the U.S. Food and Drug Administration on July 1, 2026. The action covers the Abiomed Impella CP Set with SmartAssist (10th Generation). These sets contain affected 14Fr Low Profile Introducer Kits. The FDA assigned it recall number Z-2601-2026 and classified it as Class I. That is the agency’s most serious recall category. If you or a family member received Impella heart pump support recently, this notice may matter to you.
What the Abiomed Impella Recall Covers
The abiomed impella recall applies to a specific device configuration, not the entire Impella product line. The recalled item is the Abiomed Impella CP Set with SmartAssist (10th Generation). The problem sits with the 14Fr Low Profile Introducer Kits packaged inside those sets. The FDA record lists two product codes: 1000413 and 1000834.
The Impella CP is a percutaneous heart pump. Doctors place it through an artery to support the left side of the heart. Hospitals use it during high-risk cardiac procedures and in some cases of cardiogenic shock. The introducer is the sheath that creates the access path for the pump. It is a small component, however, and its performance affects the whole system.
The recall scope is 168 units, according to the FDA record. That is a narrow distribution compared with many device recalls. These sets go to hospitals and cardiac catheterization labs, not to consumers or retail stores. As a result, most patients will never have handled or purchased the product themselves. Your hospital or physician is the party that would have received the recall notice.
The abiomed impella recall is dated July 1, 2026. Product codes 1000413 and 1000834 are the identifiers listed in the agency record. If you want to confirm whether a specific device was involved, those codes are the starting point. Typically, hospital biomedical or cardiology departments track this information by lot and serial number.
The Hazard and Reported Injuries
The hazard described in the FDA record is the potential for thrombus formation during prolonged use of the introducer. Thrombus is the clinical word for a blood clot. Clots can form on or around devices placed inside blood vessels. The risk noted here is tied to extended use of the introducer, not brief use.
Clot formation in an arterial device is a serious concern in general medicine. A clot can restrict blood flow at the access site. It can also travel to other parts of the body. That is why the FDA reserves the Class I label for situations where a reasonable probability of serious injury or death exists. The classification reflects potential risk, not a count of confirmed harm.
Whether injuries have been reported in connection with this abiomed impella recall is not stated in the agency record reviewed here. For that reason, this guide does not claim that injuries occurred, and it does not claim that none occurred. Readers should not read the Class I label as proof of a specific patient outcome. In most cases, only the treating medical team can speak to an individual patient’s course.
| Recall number | Z-2601-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | July 1, 2026 |
| Company | Abiomed, Inc. |
| Product | Impella CP Set with SmartAssist (10th Generation), product codes 1000413 and 1000834 |
| Units affected | 168 |
| Severity | Class I |
The table above reflects the verified agency record for the abiomed impella recall. Nothing beyond those fields should be assumed. For example, unit counts sometimes change as a company completes its accounting. Always treat the official FDA notice as the current authority.
What To Do If You Own This Product
This is a hospital-use cardiac device. As a result, ordinary consumers do not own it or store it at home. If you are a clinician, hospital administrator, or biomedical technician, the first step is to check your inventory. Look for the Impella CP Set with SmartAssist (10th Generation) and product codes 1000413 and 1000834.
The remedy details for this abiomed impella recall are not restated in this guide. The remedy text in the agency database did not match the product involved, so it has been withheld here to avoid confusion. Instead, follow the instructions in the official notice linked on this page. That notice is the authoritative source for handling, return, or correction steps.
If you are a patient, you likely cannot check anything yourself. However, you can contact the hospital or cardiology practice that performed your procedure. Ask whether the device used in your case falls within the abiomed impella recall. Ask whether any follow-up monitoring is recommended for you. Bring the date of your procedure and the facility name to that conversation.
Keep records. Save discharge summaries, procedure reports, and billing statements. These documents often list device identifiers. Typically, they are also the fastest way to answer questions later. Do not stop or change any prescribed treatment on your own. Any medical decision should come from your treating physician, not from a recall notice.
Does a Abiomed Impella Recall Mean You Can Sue?
No. A recall is a safety action, not a lawsuit. When the FDA classifies an abiomed impella recall, it is flagging a potential risk in a product. It is not making a finding of legal liability. The two processes are separate, and they follow different rules and different standards of proof.
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A legal claim generally requires more than a recall notice. In most cases, a person must show an actual injury. They must also show that the product defect caused that injury. Causation is often the hardest part, especially with cardiac devices used in critically ill patients. Underlying illness can complicate the picture significantly.
If you believe you were harmed, you may be eligible to pursue a claim. That is not a promise of compensation, and no outcome can be guaranteed. Only a licensed attorney who reviews your medical records can assess your situation. Deadlines called statutes of limitations also apply, and they vary by state.
Be cautious with any source that guarantees money. Legitimate attorneys evaluate facts before offering an opinion. For example, they will want procedure dates, device identifiers, and complete medical records. This guide is educational information only. It is not legal advice, and reading it does not create an attorney-client relationship.
How Recalls Connect to Mass Tort Cases
Recalls and litigation sometimes intersect over time. A recall notice can become a document in later civil cases. It may show what a company knew and when it acted. However, a recall by itself does not establish that a company was negligent. Courts require evidence developed through discovery and expert testimony.
History offers examples of this pattern. The Philips CPAP and BiPAP recall of 2021 involved sound-abatement foam degradation. Thousands of claims followed and were consolidated into multidistrict litigation. The Takata airbag inflator recalls became one of the largest automotive recall events on record, and extensive litigation followed. In each case, the recall was a starting point, not the conclusion.
No lawsuit over this specific abiomed impella recall has been verified for this guide. That absence is worth stating plainly. Readers should not assume that litigation exists simply because a Class I recall was issued. If that changes, the official court dockets and the FDA database will reflect it. Typically, those public sources are the most reliable way to track developments.
Frequently Asked Questions
What product does the abiomed impella recall cover?
It covers the Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. The FDA record lists product codes 1000413 and 1000834. The scope is 168 units.
What does a Class I recall mean?
Class I is the FDA’s most serious recall category. It signals a reasonable probability that use of the product could cause serious injury or death. It describes potential risk, and it is not a count of confirmed injuries.
How do I find out what to do with an affected device?
Follow the instructions in the official FDA notice linked on this page. Hospital staff should also contact Abiomed directly through the channels named in that notice. Patients should speak with the facility that performed their procedure.
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.