Recall Summary
| Recall number | Z-2685-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-07-22 |
| Company | Abiomed, Inc. |
| Units affected | 1,540 |
| 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 notices are drawing attention from patients, families, and hospital staff this summer. On July 22, 2026, the U.S. Food and Drug Administration published a Class I recall involving Abiomed, Inc. The action covers the ABIOMED Impella CP Introducer Kit, a component used with the Impella heart pump. A Class I designation is the most serious recall category the FDA uses. It means the agency believes use of the product could cause serious harm. This guide explains what the recall covers and what to do next.
What the Abiomed Impella Recall Covers
The abiomed impella recall covers the ABIOMED Impella CP Introducer Kit, 14 Fr, 13 cm. The affected pump set carries code 0052-0038. Inside that set is the Kit, 14Fr Introducer, 13cm, Long Taper. The introducer itself carries product code 0052-3052. These parts belong to the Impella family of heart pumps and accessories. The Impella is a small pump that supports the heart during certain cardiac procedures.
An introducer sheath is a thin tube placed into a blood vessel. Clinicians use it to guide the pump into position. It seems like a small part. However, it plays a direct role in keeping the procedure safe and controlled. A defect in the introducer can affect the entire procedure. That is why the FDA treated this issue with its highest level of concern.
The FDA record lists 1,540 units within the scope of this action. The official recall number is Z-2685-2026. The agency dated the recall July 22, 2026. Hospitals and cardiac catheterization labs are the typical end users of these kits. In most cases, individual patients never see the packaging or product codes. The devices are stocked, opened, and used by clinical teams during procedures.
One detail in the abiomed impella recall deserves special attention. The FDA record states that 14Fr or 23Fr introducers are provided in every pump set. As a result, the affected component is not a rare add-on. It ships as a standard part of the sets described in the notice. Facilities should check their inventory against the exact codes above. The official FDA notice contains the authoritative product identification details.
The Hazard and Reported Injuries
The core problem in the abiomed impella recall is potential introducer sheath leakage. According to the FDA, leakage can occur from under the sheath cap. It can also occur along the hub score lines. The agency identified these issues in both 14Fr and 23Fr introducers. The cause traces back to manufacturing issues. Critically, the FDA states these defects are not visually detectable by the user. A clinician cannot spot the flaw by inspecting the device.
Why does leakage matter? The introducer sheath sits inside a major blood vessel during use. A leak at the sheath can compromise the seal the device is supposed to maintain. For example, a compromised seal could allow blood loss during a procedure. Impella devices are typically used in patients who are already seriously ill. These patients have little reserve to tolerate added complications. That vulnerability is part of why the FDA assigned a Class I severity level.
The FDA record for this recall does not state whether injuries have been reported. This guide will not speculate either way. What the record does confirm is the risk profile the agency assigned. Class I means the FDA believes there is a reasonable probability of serious harm. The table below summarizes the verified details of the abiomed impella recall.
| Recall Number | Z-2685-2026 |
|---|---|
| Issuing Agency | U.S. Food and Drug Administration |
| Recall Date | July 22, 2026 |
| Company | Abiomed, Inc. |
| Units Affected | 1,540 |
| Severity | Class I (most serious) |
What To Do If You Own This Product
The abiomed impella recall mostly affects hospitals rather than home users. Impella pumps and introducer kits are professional medical devices. However, patients and families still have a role to play. If you or a loved one recently had an Impella-supported procedure, stay informed. You can ask the treating hospital whether recalled introducer kits were involved. Keep copies of discharge papers and device records if you have them.
Hospitals and clinical teams should act on the official notice directly. Check inventory for pump set code 0052-0038 and introducer product code 0052-3052. Remember that the defect cannot be seen during inspection. As a result, visual checks are not a substitute for following the recall instructions. Quarantine decisions should follow the guidance in the official notice, not internal judgment alone.
Follow the instructions in the official FDA notice for the specific remedy steps. The notice is available at the FDA medical device recall database. Search for recall number Z-2685-2026 to find the full record. Facilities with questions can also contact Abiomed directly through the channels listed there. Typically, device recalls include instructions for returning or handling affected stock.
Patients should never stop or alter medical care because of a recall headline. Decisions about cardiac support devices belong with your care team. If you have concerns, raise them with your cardiologist or surgeon. Ask whether the abiomed impella recall affects any device used in your care. Write down the answers, including dates and names. Those records may matter later if questions arise about your treatment.
Does a Abiomed Impella Recall Mean You Can Sue?
A recall is not a lawsuit. This point matters, so we will say it plainly. The abiomed impella recall is a safety action coordinated with the FDA. It exists to remove potentially defective products from use. It is not a court finding, an admission of liability, or a settlement program. No one automatically receives money because a product they encountered was recalled.
That said, recalls and lawsuits can intersect. A legal claim generally requires two things beyond the recall itself. First, an actual injury must have occurred. Second, there must be evidence connecting that injury to the defect. For example, a patient who suffered documented complications during an Impella procedure might ask hard questions. Whether those complications trace back to a leaking introducer is a medical and legal question.
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If you believe a recalled device harmed you, speak with a licensed attorney. Most product liability lawyers offer free initial consultations. Bring your medical records, procedure dates, and any device documentation. An attorney can evaluate whether injury and causation support a claim. You may be eligible for compensation if both elements are present. However, no outcome is guaranteed, and every case turns on its own facts.
Deadlines also matter. Every state sets time limits, called statutes of limitations, for injury claims. These clocks can start at the injury or at its discovery. In most cases, waiting too long can end a valid claim before it starts. That is another reason to seek qualified legal advice early rather than late. A short consultation now can preserve options you might otherwise lose.
How Recalls Connect to Mass Tort Cases
Recalls often become important evidence in later litigation. A recall notice documents the defect, the timeline, and the company’s response. Lawyers use those records to show what a manufacturer knew and when. The Philips CPAP recall is a well-known example. Philips recalled millions of breathing machines in 2021 over degrading sound-abatement foam. That recall became a foundation for large-scale litigation that followed.
The Takata airbag recall tells a similar story. Defective inflators led to the largest automotive recall in U.S. history. The recall records helped injured drivers build claims against the manufacturer. Mass tort cases form when many people allege similar injuries from the same product. Courts often consolidate these claims to handle them efficiently. A recall alone does not create a mass tort, but it can supply key evidence.
Whether the abiomed impella recall leads to litigation is unknown at this time. This guide has not verified any lawsuit tied to this specific recall. Readers should be skeptical of anyone claiming a settlement already exists. Typically, litigation develops slowly, if it develops at all. MassTortInfo.com will update this guide if the legal landscape around this recall changes.
Frequently Asked Questions
Is the abiomed impella recall dangerous for current patients?
The FDA classified it as Class I, its most serious category. That reflects potential for serious harm from introducer sheath leakage. Patients should direct questions about their own care to their treating physicians.
How do I know if my hospital used a recalled kit?
Ask the hospital or your care team directly and reference recall number Z-2685-2026. The affected pump set code is 0052-0038, with introducer product code 0052-3052. Hospitals maintain device records that can confirm what was used in your procedure.
Does the abiomed impella recall mean I will get compensation?
No. A recall is a safety action, not a payment program or lawsuit. You may be eligible to pursue a claim only if you suffered an injury linked to the defect, so consult a licensed attorney.
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.