ABIOMED Impella CP Introducer Kit 14 Fr Recall: What To Do

The abiomed impella recall is a Class I action announced by the U.S. Food and Drug Administration on July 22, 2026. It involves the ABIOMED Impella CP Introducer Kit 14 Fr, sold by Abiomed, Inc. The FDA assigned it recall number Z-2683-2026. A total of 846 units are affected.

The concern is a potential for introducer sheath leakage that a clinician cannot see. Class I is the FDA’s most serious recall category. If you or a family member had an Impella heart pump procedure, this guide explains what the record says.

What the Abiomed Impella Recall Covers

The abiomed impella recall covers a specific introducer kit used with the Impella CP heart pump system. The FDA record names the ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm. The pump set code is 1000550. The kit itself is described as “Kit, 14Fr Introducer, 13cm&25cm, Sterile.” The introducer product code is 0052-3046.

An introducer sheath is a short tube. Clinicians place it into a blood vessel to create an access path. The heart pump and its catheter then pass through that sheath. For example, in a cardiac procedure, the sheath holds the vessel open. It is a small component, but it sits directly in the bloodstream.

The agency record for this abiomed impella recall lists 846 units in scope. That is a modest number by consumer-product standards. However, this is not a consumer product. Each unit is used in a hospital setting on a patient who is often critically ill. As a result, a small unit count can still carry real clinical weight.

This is a hospital-supplied device. Patients do not buy it, store it, or own it. In most cases, you would never see the packaging or product code. Hospitals, cardiac catheterization labs, and health systems are the parties who receive these recall notices directly. The FDA record does not list specific retail locations, because there are none.

The Hazard and Reported Injuries

The FDA describes the hazard as a potential for introducer sheath leakage. The leakage may occur from under the sheath cap. It may also occur along the hub score lines. The agency identified these manufacturing issues in 14Fr and 23Fr Introducers.

Two details in the record matter most. First, the FDA states these manufacturing issues are not visually detectable by the user. A clinician inspecting the kit would not see the defect. Second, the record states that 14Fr or 23Fr Introducers are provided in every pump set. That broadens the practical footprint of the issue.

The FDA classified this abiomed impella recall as Class I. Class I is reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. That classification reflects the agency’s risk judgment. It is not, by itself, a finding that harm occurred.

Importantly, the agency record for this abiomed impella recall does not state whether injuries have been reported. We will not claim that injuries occurred. We also will not claim that none occurred. Typically, injury data for device recalls surfaces later through separate FDA adverse event reporting. Readers should rely on the official notice for updates.

What To Do If You Own This Product

Almost no individual reader “owns” this product. This abiomed impella recall involves hospital inventory, not household goods. If you work in a cardiac cath lab, materials management, or hospital supply chain, you are the likely recipient of the notice. Check your inventory against pump set code 1000550 and introducer product code 0052-3046.

We are not stating what the remedy is. The agency record for this recall contains remedy text that does not match the product, so we have withheld it. Do not guess at the correct action. Follow the instructions in the official notice linked on this page instead.

The official FDA notice is here: FDA recall database entry for Z-2683-2026. That database is the authoritative source. It will carry the correct remedy language, contact details, and any updates. Abiomed, Inc. is the responsible company for questions about affected lots.

If you are a patient, take a different path. You cannot inspect or return this device. However, you can ask your treating cardiologist whether an Impella CP device was used in your procedure. For example, ask whether the introducer kit came from a recalled lot. Request your procedure records and device implant documentation in writing.

Keep everything you receive. Save discharge summaries, operative notes, and device stickers. As a result of good recordkeeping, you will be far better positioned if questions arise later. Report any suspected device problem to the FDA’s MedWatch program and to your hospital.

Does a Abiomed Impella Recall Mean You Can Sue?

A recall is not a lawsuit. That distinction matters, and it is often misunderstood. The abiomed impella recall is a regulatory safety action. The FDA classifies risk and the company addresses affected product. No court has decided anything by issuing a recall.

A recall alone is not a legal claim. In most cases, a personal injury claim requires several elements. There must be a defect. There must be an actual injury. And there must be causation linking the defect to that injury. A recall notice may be useful evidence toward the first element. It does not supply the other two.

We are not aware of, and are not stating, that any lawsuit exists over this specific abiomed impella recall. If you were harmed during or after a procedure involving this device, you may be eligible to pursue a claim. Whether you actually have one depends on your medical facts. Nobody can tell you that you are owed anything.

Talk to a licensed attorney in your state. Medical device claims are complex. They can involve federal preemption issues that do not apply to ordinary product cases. Deadlines called statutes of limitations also apply, and they vary. No outcome is guaranteed, and this page is not legal advice.

How Recalls Connect to Mass Tort Cases

Recalls and mass torts are separate tracks that sometimes intersect. A recall documents that a manufacturer identified a problem. It creates a paper trail with dates, lot numbers, and hazard descriptions. Later, if injured people file suit, that paper trail can become evidence. It can help establish what a company knew and when it knew it.

History shows the pattern. The Philips CPAP and BiPAP recall began in June 2021 over degrading sound abatement foam. Thousands of lawsuits followed and were consolidated into multidistrict litigation. Takata airbag inflators were recalled across many automakers, and litigation followed there too. However, neither recall automatically created liability.

The lesson is about sequence, not certainty. Typically, a recall comes first, adverse event reports accumulate, and claims follow only if injuries and causation can be shown. Many recalls, including serious Class I ones, never produce litigation at all. For example, a defect caught before any patient harm may end quietly. The abiomed impella recall currently sits in the regulatory stage, and nothing here suggests otherwise.

Frequently Asked Questions

What does a Class I classification mean in the abiomed impella recall?

Class I is the FDA’s most serious recall category. It means there is a reasonable probability that use of the product could cause serious health consequences or death. It is a risk classification, not a finding that anyone was hurt.

How many units are covered by this recall?

The FDA record lists 846 units for recall number Z-2683-2026. These are hospital-supplied introducer kits, not consumer items. The affected products are identified by pump set code 1000550 and introducer product code 0052-3046.

Were any injuries reported in the abiomed impella recall?

The agency record does not state whether injuries have been reported. For that reason, we make no claim in either direction. Check the official FDA notice linked on this page for the current status.

What should I do about the recalled product?

We are not stating the remedy, because the remedy text in the agency record does not match this product. Follow the instructions in the official notice linked on this page. Hospitals and clinicians should contact Abiomed, Inc. directly with inventory questions.

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 August 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.