Amplatzer Steerable Delivery Sheath Lawsuit: What Patients Should Know About the Abbott Recall and Air Embolism Claims

If you or a family member underwent a cardiac catheter procedure using the Abbott Amplatzer Steerable Delivery Sheath and experienced complications, you may be wondering whether legal claims are moving forward. Abbott recalled the device in 2023 after reports that it could introduce air into the bloodstream during heart procedures, a complication that can cause stroke, organ damage, or death.

The litigation is in its early stages. No settlements or trial verdicts have been publicly announced as of mid-2026. This post explains what the device is, why the FDA classified the recall at its most serious level, what injuries have been reported, and what patients considering legal action need to understand.

This article provides general legal and medical-device information. It is not legal advice. If you believe you were harmed by this device, consult a licensed attorney in your state who handles medical device litigation.

What the Amplatzer Steerable Delivery Sheath Actually Does

The Amplatzer Steerable Delivery Sheath is a cardiac catheter manufactured by Abbott (formerly St. Jude Medical). It is inserted through the skin, typically via the femoral vein in the groin, and guided into the heart's chambers. Its primary purpose is to provide a pathway so that other catheter-based devices can be delivered into the heart.

The sheath was specifically designed to deliver the Amplatzer Amulet Left Atrial Appendage Occluder, a device used to seal off the left atrial appendage in patients with atrial fibrillation who cannot take long-term blood thinners. The left atrial appendage is a small pouch in the heart where blood clots tend to form in patients with atrial fibrillation, and closing it off is intended to reduce stroke risk.

Because the sheath must navigate through the heart's chambers and cross the atrial septum (the wall between the heart's upper chambers), it is designed with a steerable tip that allows the interventional cardiologist to position it precisely. That steerability, however, is part of what created the problem Abbott eventually disclosed.

Why Abbott Recalled the Device

In 2023, Abbott issued a voluntary recall of the Amplatzer Steerable Delivery Sheath. The FDA classified it as a Class I recall, the most serious category the agency assigns. Class I means the FDA has determined that use of the device could cause serious injuries or death.

The specific concern was air embolism: the risk that air could enter the sheath during the procedure and travel into the patient's bloodstream and heart chambers. An air embolism occurs when a bubble of air (or, in some cases, a larger volume) enters the vascular system. In the context of a cardiac catheter procedure, air introduced directly into the heart's left side can travel to the brain and cause a stroke, or it can block blood flow in coronary arteries and cause a heart attack.

According to the FDA's recall notice, the issue stemmed from the sheath's design or construction allowing air ingress during use. The recall affected sheaths distributed over a period prior to the recall announcement, meaning patients who underwent procedures during that window may have been exposed to the defect.

Abbott's own cardiovascular product advisories page lists device corrections and recalls for its cardiac products, though the specific Amplatzer sheath advisory details have been communicated directly to healthcare providers who used the device.

The Injuries Linked to the Sheath

The core injury alleged in the litigation is air embolism and its downstream consequences. An air embolism during a cardiac catheterization is not always immediately obvious, and its severity depends on the volume of air introduced and where it travels. Reported injuries include:

Stroke. When air travels from the left side of the heart into the arteries supplying the brain, it can block blood flow and cause an ischemic stroke. Depending on the size and location of the blockage, the effects can range from temporary neurological symptoms to permanent disability or death.

Heart attack. Air entering the coronary arteries can obstruct blood flow to the heart muscle itself, causing myocardial ischemia or infarction.

Organ damage. Air emboli can travel to other organs, including the kidneys, intestines, or extremities, causing ischemic injury wherever they lodge.

Death. Large-volume air embolisms or those that occur in critical vascular beds can be fatal, particularly if not recognized and treated immediately.

It is worth understanding that air embolism is a known, if uncommon, risk of any cardiac catheterization procedure. What distinguishes the Amplatzer sheath situation is the allegation that the device's design or manufacturing defect made air embolism substantially more likely than it should have been, elevating what should be a rare procedural risk into something that occurred with enough frequency to trigger a Class I recall.

Where the Litigation Stands

As of mid-2026, lawsuits against Abbott related to the Amplatzer Steerable Delivery Sheath are in their early stages. Key points about the current state of the litigation:

No MDL has been publicly established. Unlike larger medical device mass torts (such as the Bard PowerPort catheter litigation in MDL 3081 or the Cook IVC filter cases centralized in MDL 2570), the Amplatzer sheath claims have not been consolidated into a multidistrict litigation as of this writing. If the number of federal cases grows, the Judicial Panel on Multidistrict Litigation could centralize them, but that step has not occurred yet based on publicly available information.

No settlements or verdicts. There are no reported settlement agreements or jury verdicts in Amplatzer sheath cases. The litigation has not progressed to the discovery, expert, or trial phases that typically precede resolution in medical device cases.

Some law firms have stopped accepting cases. At least one major legal resource has noted that its legal partners are no longer accepting new Amplatzer sheath cases, which may reflect the relatively small number of affected patients, difficulties in proving device-specific causation, or strategic decisions by plaintiff firms about case viability. This does not mean claims are impossible to pursue, but it does suggest that the litigation has not gained the momentum seen in larger device mass torts.

Individual lawsuits may still be filed. Even without an MDL or widespread attorney advertising, individual patients who suffered air embolism or related injuries during procedures using the recalled sheath can pursue claims in state or federal court. The viability of any individual case depends on the specific facts: whether the recalled lot was used, whether the injury is consistent with air embolism, and whether medical records support a causal connection.

Legal Theories in Medical Device Cases Like This One

Medical device lawsuits typically proceed under several legal theories. While the specific claims in Amplatzer sheath cases will depend on the jurisdiction and the facts, the general categories include:

Strict product liability (design defect). The plaintiff argues that the sheath was defectively designed because it allowed air ingress during normal use. The Class I recall and the FDA's finding of increased air embolism risk support this theory, though a recall alone does not automatically establish liability at trial.

Manufacturing defect. If the issue affected specific production lots rather than the design as a whole, claims may focus on manufacturing quality control failures.

Failure to warn. Plaintiffs may argue that Abbott did not adequately warn healthcare providers about the air embolism risk before the recall, or that warnings were delayed. The timing between when Abbott became aware of adverse events and when it issued the recall is often a central issue in these cases.

Negligence. A broader claim that Abbott failed to exercise reasonable care in designing, manufacturing, testing, or monitoring the device.

One significant legal consideration in medical device cases is federal preemption. Under the Supreme Court's decision in Riegel v. Medtronic (2008), devices that received premarket approval (PMA) from the FDA may be shielded from state-law design defect claims because the FDA already reviewed and approved the design. Whether the Amplatzer Steerable Delivery Sheath went through the PMA process or was cleared through the less rigorous 510(k) pathway matters significantly. Devices cleared through 510(k) generally do not receive the same preemption protection. Patients considering litigation should discuss this issue with an attorney familiar with the device's regulatory history.

How Medical Device Statutes of Limitations Work

Every state imposes a deadline for filing a personal injury lawsuit, known as the statute of limitations. In most states, this period runs two to three years from the date of injury or, in some jurisdictions, from the date the patient discovered (or reasonably should have discovered) that the device caused their injury. The discovery rule can be important in medical device cases because patients may not immediately connect post-procedure complications to a device defect, especially if they were not informed about the recall.

These deadlines vary by state, and missing them typically bars the claim permanently. Anyone who believes they were injured by the Amplatzer Steerable Delivery Sheath should consult an attorney promptly to determine the applicable deadline in their jurisdiction.

What Patients Should Do Now

If you underwent a procedure using the Amplatzer Steerable Delivery Sheath and experienced complications such as stroke, heart attack, or other unexplained events during or shortly after the procedure, consider these steps:

Request your medical records. Obtain the operative report and device records from the hospital or catheterization lab where the procedure was performed. These records should identify the specific device used, including the manufacturer, model, and lot number. Confirming that the recalled sheath was used in your procedure is a necessary first step.

Talk to your cardiologist. Ask whether the device used in your procedure was subject to the recall and whether your complications could be consistent with air embolism. Your treating physician's assessment of causation will be relevant to any legal claim.

Consult an attorney experienced in medical device litigation. Because the litigation is early-stage and the legal landscape (including preemption questions) is complex, an attorney who regularly handles defective medical device cases can evaluate whether your facts support a claim. Many plaintiff firms in this area offer free initial consultations. Be mindful that some firms have stopped accepting these particular cases, so you may need to contact several.

Preserve all records. Keep copies of medical records, correspondence from the hospital or device manufacturer, and any recall notices you received. If you experienced a complication and filed a report with the hospital's patient safety office, retain that documentation as well.

How This Fits Into the Broader Medical Device Litigation Landscape

The Amplatzer sheath situation shares characteristics with other medical device recalls that led to litigation: a Class I recall triggered by serious adverse events, a manufacturer (Abbott) with substantial resources, and injuries that are severe but may affect a relatively small patient population. Compared to mass torts involving devices implanted in hundreds of thousands of patients (like hernia mesh litigation or IVC filter cases), the Amplatzer sheath population is smaller because the device is used in a specialized cardiac procedure performed at a limited number of centers.

That smaller scale does not make individual claims less valid, but it does affect the litigation's trajectory. Smaller case inventories are less likely to attract MDL consolidation, less likely to generate the plaintiff-side infrastructure (common benefit funds, steering committees, shared expert discovery) that drives mass tort settlements, and more likely to proceed as individual cases in state courts. Patients in this situation may face a more traditional litigation path: filing an individual lawsuit, conducting case-specific discovery, and potentially going to trial or negotiating an individual settlement.

The Bottom Line

The Amplatzer Steerable Delivery Sheath recall is a serious event. The FDA's Class I classification, the most urgent recall category, reflects a genuine risk of life-threatening air embolism. But the litigation is early, the number of filed cases appears modest, and no outcomes have been reported. Patients who were harmed have potential legal options, but those options depend on individual facts, timing, and jurisdiction. Speaking with a qualified medical device attorney sooner rather than later is the most important step.