Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Recall: What To Do

abiomed fr recall notices matter because this device is used in critical heart procedures. On July 1, 2026, the U.S. Food and Drug Administration recorded a Class I recall for the Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. The recall number is Z-2600-2026.

Abiomed, Inc. is the company involved. The hazard is the potential for thrombus formation during prolonged use of the introducer. A Class I designation is the FDA’s most serious category. It means the agency believes there is a reasonable probability that use of the product could cause serious health consequences.

What the Abiomed Fr Recall Covers

The abiomed fr recall applies to a narrow, clearly identified product. The recalled item is the Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. The Impella Set Product Code is 1000435. The Introducer Product Code is also listed as 1000435 in the agency record. Those product codes are the primary way hospitals and clinicians identify affected inventory.

An introducer is a short sheath. It creates a working channel into a blood vessel. Through that channel, a clinician advances a device. In this case, the device is the Impella CP heart pump. The Impella CP is a temporary mechanical circulatory support device. It is used in hospital settings during high-risk cardiac procedures and in some cases of cardiogenic shock. This is not a consumer product. Typically, patients never handle it themselves.

The scope of the abiomed fr recall is 17 units. That is a very small number. However, scope and severity are separate things. A recall covering few units can still be Class I. The FDA classifies based on the potential health consequence, not on how many units shipped. For example, a device used in a life-support setting can carry high risk even in tiny quantities.

The agency record does not list lot codes or distribution dates beyond what appears above. As a result, the product codes are the reliable identifier. Hospitals, cath labs, and cardiac surgery departments should check inventory against product code 1000435. The official notice linked on this page is the authoritative source for identification details. Do not rely on secondhand summaries when checking stock.

The Hazard and Reported Injuries

The stated hazard in the abiomed fr recall is the potential for thrombus formation during prolonged use of the introducer. A thrombus is a blood clot that forms inside a blood vessel or on a device surface. Clots are a known general risk in vascular access and mechanical circulatory support. That is why anticoagulation and monitoring protocols exist in these procedures.

Clot formation on or near an introducer can create several downstream concerns. A clot can restrict blood flow at the access site. It can also break loose and travel elsewhere in the circulation. In most cases, clinical teams monitor for these risks closely. However, the FDA identified this specific product and use scenario as warranting a Class I recall.

The agency record does not state whether injuries have been reported in connection with this recall. This guide does not claim that injuries occurred. It also does not claim that none occurred. The record is simply silent on that point. Readers should treat any outside claim about injury counts with caution unless the FDA or the company confirms it.

The core facts of the abiomed fr recall are summarized below.

What To Do If You Own This Product

Because this is a hospital device, most readers will not have one at home. The people who need to act are hospital supply staff, cath lab managers, and biomedical inventory teams. Typically, the manufacturer sends an urgent notice directly to affected facilities. That notice is the document to follow.

The first practical step is identification. Check inventory for the Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Match against product code 1000435. Pull matching units from active use pending review. Then follow the instructions in the official notice linked on this page. This guide does not state what the correction or removal action is, because the agency remedy text on file does not match this product.

Facilities should contact Abiomed, Inc. directly for confirmation. Ask specifically about the units you hold and about product code 1000435. Reference recall number Z-2600-2026 in any communication. For example, keeping a written record of that contact is good practice. It documents what you were told and when.

Patients who received an Impella CP procedure should talk to their treating cardiologist. Do not stop or change any medication based on a recall notice. Ask whether the specific introducer used in your case falls within the abiomed fr recall. Request that the answer be noted in your medical record. In most cases, your hospital can look this up from procedure logs.

Does a Abiomed Fr Recall Mean You Can Sue?

A recall is a safety action. It is not a lawsuit. The abiomed fr recall is a regulatory step taken to remove or correct a product. It does not by itself establish that anyone was hurt. It also does not establish that a company acted wrongfully. Those are separate legal questions decided under different standards.

A legal claim generally requires more than a recall notice. Typically, it requires an actual injury. It also requires causation, meaning a link between the product and the harm. Medical cases add complexity, because patients receiving an Impella CP are often already critically ill. Separating device-related harm from underlying illness takes expert review of medical records.

If you or a family member had a complication after a procedure involving this device, you may be eligible to pursue a claim. That depends on the facts. It is not a guarantee, and no outcome or amount can be promised here. Deadlines called statutes of limitation also apply, and they vary by state.

The right step is to consult a licensed attorney in your state who handles medical device cases. Bring your procedure records, discharge summary, and any device stickers or implant cards. As a result of that review, an attorney can tell you whether the facts support a claim. This guide is educational and is not legal advice.

How Recalls Connect to Mass Tort Cases

Recalls often become evidence in later litigation. A recall notice can show what a company knew and when it knew it. It can also show how a defect was described in the company’s own words. However, a recall alone rarely decides a case. Courts still require proof of injury and causation for each individual plaintiff.

History shows the pattern. The Philips CPAP and BiPAP recall in 2021 involved sound abatement foam that could degrade. Thousands of claims were later consolidated into multidistrict litigation. The Takata airbag inflator recalls became one of the largest automotive recall events on record and led to extensive litigation. In both examples, the recall came first and litigation followed as injury evidence developed. Whether anything comparable follows the abiomed fr recall is unknown today, and this guide makes no prediction.

Frequently Asked Questions

How serious is a Class I 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 problems or death. It reflects potential risk, not confirmed harm in every case.

Were any injuries reported in the abiomed fr recall?

The FDA record for recall Z-2600-2026 does not state whether injuries were reported. This guide will not claim injuries did or did not occur. Check the official notice linked on this page for any updates from the agency or the company.

What should a hospital do with affected units?

Identify units matching product code 1000435 and remove them from active use pending review. Then follow the instructions in the official notice linked on this page and contact Abiomed, Inc. directly. Reference recall number Z-2600-2026 when you do.

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.