Recall Summary
| Recall number | Z-2682-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-07-22 |
| Company | Abiomed, Inc. |
| Units affected | 87,277 |
| 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 impella recall news broke on July 22, 2026, when the U.S. Food and Drug Administration posted a Class I recall of the ABIOMED Impella CP Set. Abiomed, Inc. is the recalling company. The action covers 87,277 units. It involves a potential leak in the introducer sheath included with every pump set. Class I is the FDA’s most serious recall category. It is reserved for problems that could cause serious injury or death. This guide explains what the recall covers, what the hazard is, and what steps to take now.
What the Abiomed Impella Recall Covers
The abiomed impella recall covers the ABIOMED Impella CP Set. The pump set carries code 0048-0003. Each set contains the Impella Introducer, 14 Fr, in 13 cm and 25 cm lengths. The introducer carries product code 0052-3046. The Impella CP is a temporary heart pump with accessories. Hospitals use it to support the heart during certain cardiac procedures. It is placed through an artery, and the introducer sheath creates that entry pathway.
The FDA assigned recall number Z-2682-2026 to this action. The agency posted the recall on July 22, 2026. It classified the action as Class I. That is the highest severity level the FDA uses. It means there is a reasonable probability that the product could cause serious harm. In most cases, Class I recalls demand immediate attention from hospitals and clinical teams. This one is no different.
The scope is significant. The recall affects 87,277 units. The manufacturing issue was identified in 14Fr and 23Fr Introducers. However, the FDA record notes that a 14Fr or 23Fr Introducer is provided in every pump set. As a result, the concern is not limited to a few isolated lots. That broad reach is a key reason the abiomed impella recall matters to so many hospitals and patients.
Abiomed, Inc. is the manufacturer behind the Impella line. Its heart pumps are widely used in U.S. catheterization labs. Typically, these devices support patients during high-risk procedures or episodes of cardiogenic shock. Those are already fragile clinical moments. The recall does not remove the entire Impella platform from the market. It targets the specific pump sets and introducers identified in the FDA record.
The Hazard and Reported Injuries
The core problem is potential introducer sheath leakage. According to the FDA record, leaks can occur from under the sheath cap. They can also occur along the hub score lines. These manufacturing issues were identified in 14Fr and 23Fr Introducers. Crucially, the defects are not visually detectable by the user. A trained clinician cannot spot the flaw by inspecting the device before use. That hidden nature makes the abiomed impella recall especially serious.
The introducer sheath must hold a secure seal while the pump is placed into an artery. A leaking sheath can compromise that seal during a procedure. Blood loss at the access site is one possible concern. A disrupted procedure at a critical moment is another. Patients who need an Impella pump are often in unstable condition already. For example, many are in cardiogenic shock or undergoing high-risk interventions. Any device failure in that setting carries real weight.
The agency record does not state whether injuries have been reported. This guide will not speculate in either direction. Even so, the Class I designation speaks for itself. The FDA reserves that classification for hazards with a reasonable probability of serious injury or death. Readers should treat the recall with that level of seriousness. The table below summarizes the verified facts.
| Recall Number | Z-2682-2026 |
|---|---|
| Issuing Agency | U.S. Food and Drug Administration |
| Date Posted | July 22, 2026 |
| Company | Abiomed, Inc. |
| Units Affected | 87,277 |
| Severity | Class I (most serious) |
Class I recalls of heart support devices are uncommon but not unheard of. They typically trigger urgent communication between the manufacturer and hospitals. Facilities are expected to act quickly on the official instructions. Patients, meanwhile, are often left with questions. The sections below address the most practical ones.
What To Do If You Own This Product
The Impella CP is not a consumer product. Patients do not keep it at home. Hospitals, cath labs, and surgical departments hold the affected inventory. If you manage medical supplies, check your stock now. Look for pump set code 0048-0003. Also look for introducer product code 0052-3046. Quarantine any matching units until you confirm the required next steps. Do not rely on visual inspection, because the defect cannot be seen.
The official notice is the controlling document for this abiomed impella recall. Follow the instructions in that notice exactly. You can locate the entry through the official FDA device recall database. Search for recall number Z-2682-2026 to find the exact record. The notice explains what affected facilities must do with their inventory. This page does not restate those instructions, so the official source should be your guide.
Patients have a role here too. If you or a loved one recently had an Impella-supported procedure, stay calm. Ask the hospital whether an affected pump set or introducer was used in your care. Request copies of your medical records, including any device labels or lot numbers. In most cases, procedure logs record the exact product codes used. Keep that paperwork in a safe place. It answers questions now and preserves facts for later.
Report any suspected device problems to the FDA through its MedWatch program. Clinicians and patients can both file reports. These reports help the agency track real-world performance of recalled devices. They also create a documented record of your experience. As a result, filing a report is worthwhile even if you are unsure the device caused a problem.
Does a Abiomed Impella Recall Mean You Can Sue?
A recall is not a lawsuit. That point deserves plain language. The abiomed impella recall is a safety action taken to address a potential defect. It is not a court finding of fault. It does not create automatic payments to patients. It does not mean anyone was harmed. It simply means the FDA and the company are correcting or removing a potentially dangerous product.
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A recall alone is not a legal claim. Courts generally require much more. Typically, a plaintiff must show an actual injury. The plaintiff must also connect that injury to the specific defect. Lawyers call this causation. Without both injury and causation, a recall notice by itself goes nowhere in court. However, a recall can still become powerful supporting evidence when real harm exists.
Consider how the pieces fit together. Suppose a patient suffered complications during an Impella-supported procedure. Suppose an affected introducer was used in that procedure. Questions naturally follow. Did the sheath leak? Did the leak cause or worsen the harm? These are fact-specific issues. Medical records, device logs, and expert review usually decide them, not the recall notice alone.
Talk to a licensed attorney if you believe you were injured. Many product liability lawyers offer free consultations. You may be eligible to pursue a claim if the facts support one. No outcome is ever guaranteed. Deadlines known as statutes of limitations also apply in every state. For that reason, do not wait to get your situation reviewed.
How Recalls Connect to Mass Tort Cases
Recalls often become important evidence in later litigation. A recall documents that the manufacturer and regulators identified a defect. It establishes a timeline of what was known and when. Plaintiffs’ attorneys use recall records to build that narrative. As a result, a large Class I recall sometimes precedes a wave of individual lawsuits. That happens only when injuries connected to the defect begin to surface.
History offers clear examples. The Philips CPAP recall of 2021 involved sound-abatement foam that could degrade. It eventually led to thousands of lawsuits consolidated in multidistrict litigation. The Takata airbag recalls grew into the largest automotive recall in U.S. history. They also produced massive litigation and criminal penalties. In both cases, the recall came first. The lawsuits followed as injured people came forward.
That does not mean the abiomed impella recall will follow the same path. No lawsuit over this specific recall has been verified as of this writing. Whether litigation ever develops depends on whether real injuries emerge and can be proven. For now, this recall is a safety measure. It is also a public record that may matter later. Affected patients should preserve their documents either way.
Frequently Asked Questions
Is the abiomed impella recall a Class I recall?
Yes. The FDA classified it as Class I, its most serious recall category. That level is reserved for defects with a reasonable probability of serious injury or death. The recall number is Z-2682-2026, posted on July 22, 2026.
How can a hospital or patient identify the affected product?
Check for the ABIOMED Impella CP Set with pump set code 0048-0003. The included 14 Fr introducer carries product code 0052-3046. The defect is not visually detectable, so identification must rely on these codes, not inspection.
Can I get compensation because of the abiomed impella recall?
Not automatically. A recall is a safety action, not a settlement or a lawsuit. You may be eligible to pursue a claim if you suffered a real injury linked to the defect. A licensed attorney can evaluate your specific facts.
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.