B. Braun Microbore IV Extension Injury & Wrongful Death Lawsuit Lawyers

Defective Labeling of IV Extension Sets May Lead to Fatal Air Embolism: What Patients and Families Should Know About Their Rights.

The U.S. Food and Drug Administration (FDA) has designated a Class I recall for a line of B. Braun Microbore Extension Sets because of a potentially lethal labeling defect that could result in air embolisms and death. A Class I recall signifies an issue with a product that poses a reasonable probability of serious health consequences or death. The recalled devices were labeled as including an air‑eliminating filter, a safety feature intended to prevent air from entering a patient’s bloodstream, when, in fact, the devices lack this filter.

These extension sets are single‑use medical accessories designed to connect intravenous (IV) lines, allowing medical professionals to deliver fluids, medications, and blood products safely. Because the devices were mislabeled, healthcare providers may have believed an air elimination safety component was present when it was not. This misrepresentation creates a threat to patient safety, as undetected air in an IV line can travel into the bloodstream, lodge in critical organs, and cause rapid, catastrophic injury.

No injuries have been publicly reported to B. Braun in connection with this defect at the time of this recall announcement. However, the potential for a fatal air embolism is enough for the FDA to require the highest level of recall response. Patients, family members, and caregivers who have been affected by the use of these devices are likely to have questions about their rights and potential legal remedies. If you or a loved one suffered harm after an IV procedure that involved a mislabeled B. Braun microbore extension, you may be entitled to compensation for medical costs, pain and suffering, and other losses.

What Are Microbore Extensions and How Are They Used in Medical Care?

Microbore extension sets are small, flexible tubing components used as part of IV therapy. They are often placed between the main IV line and other components such as infusion pumps, medication vials, or patient access ports. These extensions allow clinicians to administer medications, fluids, and blood products in a controlled, sterile manner and play an integral role in hospital, surgical, and emergency care settings.

The term “microbore” refers to the narrow internal diameter of the tubing. The reduced diameter is designed to minimize fluid volume in the line and enable precise medication delivery and controlled fluid flow. This is a feature that is particularly important in settings such as neonatal care, intensive care units, and postoperative recovery.

A critical safety feature on many extension sets is an air‑eliminating filter or air vent. These components are engineered to prevent air bubbles from traveling into the patient’s bloodstream. During IV therapy, air bubbles may inadvertently form in the line when connections are made, medication doses are changed, or when containers are emptied. In systems with proper air‑elimination design, small amounts of air can escape through a filter or vent before fluid enters the patient.

The B. Braun Microbore Extensions at issue were marketed with labeling indicating the presence of an air‑eliminating filter. However, the devices actually lack this safety feature. As a result, clinicians using these products under the belief that air elimination was in place may have unknowingly exposed patients to dangerous air entry during IV therapy.

Microbore extension sets are widely used across hospital departments, ambulatory care centers, and outpatient infusion services. For patients undergoing chemotherapy, hydration therapy, surgical anesthesia, or critical care monitoring, IV administration is a routine part of treatment. When a fundamental safety feature is misrepresented, it jeopardizes the trust clinicians place in medical devices and significantly increases the risk to patients.

Why the Recall Was Issued and What It Means for Patients

On January 6, 2026, the FDA announced that it was aware that B. Braun had initiated a recall of certain Microbore Extension Sets due to incorrect labeling. Patients and clinicians were informed that these devices were labeled as having an air‑eliminating filter, which is a feature necessary to push air out of IV lines and prevent air embolisms. However, the products do not contain the filter despite the labeling claims.

The recall involves all units of the affected product that are in clinical settings or inventory until the packaging can be corrected. The FDA’s Class I recall designation indicates that this is the most serious type of recall, applied when there is a reasonable probability of serious adverse health consequences or death. Even though no injuries have been confirmed, the risk of an undetected air embolism occurring during IV administration is substantial enough to mandate immediate action.

Air embolisms can occur when air enters the circulatory system and travels to the heart, lungs, or brain, blocking blood flow and causing rapid and life‑threatening effects. The mislabeling means that caregivers could rely on the perceived presence of a safety device that was not actually part of the product. This false sense of safety could delay detection of air in the IV line, exposing patients to harm.

FDA and B. Braun have instructed that all affected products be quarantined and removed from use until the packaging can be corrected to accurately reflect the product’s features. Healthcare providers were advised to discontinue the use of the mislabeled microbore sets immediately and identify alternative devices that contain proper air‑elimination capabilities.

Braun sent notifications to all known customers with instructions for returning the product and completing an Urgent Medical Device Recall Acknowledgement Form. Clinical settings and supply houses must record the remaining inventory and return the devices to the company, which will follow up to initiate the return process.

Until the corrected labeling is in place, alternative microbore extension products must be used. The FDA and B. Braun have asked that this recall notice be widely distributed to ensure all mislabeled devices are removed from patient care environments. For patients and families, this recall means that products that were assumed safe may have been used in care delivery, potentially exposing individuals to risk without their knowledge.

Health Risks Associated with Mislabeling of IV Devices

IV therapy is an essential component of modern medical care, used for delivering lifesaving medications, hydration, blood products, and anesthetics. Because it involves direct access to the bloodstream, any air introduced into an IV line can have catastrophic effects. A small amount of air can form a bubble that travels through the circulatory system. If that bubble reaches the heart or lungs, it can obstruct blood flow and lead to a condition known as an air embolism.

Medical professionals are trained to remove air from IV lines before patient connection. However, safety features like air‑eliminating filters are designed to serve as a final safeguard in clinical practice. When a product is mislabeled as containing such a filter but does not, this presumed layer of protection is absent.

Possible Consequences of Air Embolism

• Stroke: An air bubble in cerebral circulation can block vessels and deprive brain tissue of oxygen, leading to sudden neurological damage.
• Heart Attack: Air in coronary circulation can obstruct blood flow to the heart, causing cardiac arrest or myocardial infarction.
• Respiratory Failure: Air emboli in the lungs can interrupt gas exchange, resulting in acute respiratory distress.
• Severe Hypotension: Circulatory blockage can lead to a drastic drop in blood pressure, compromising organ perfusion.
• Death: In situations where large volumes of air enter circulation, the heart and lungs may fail rapidly.

Even small volumes of air that do not cause immediate death can have serious consequences, including cognitive deficits, prolonged hospitalization, long‑term physical impairment, and significant emotional trauma for patients and families.

The misrepresentation of a crucial safety component in an IV extension set undermines the assumption that such devices are adequately designed for patient safety. A patient undergoing infusion therapy relies on each component functioning as expected; a mislabeled device breaks that chain of safety and increases the risk of harm.

Who May Be Harmed by the B. Braun Microbore Recall

The recall affects any patient who received IV therapy using one of the recalled B. Braun Microbore Extension Sets. Because these devices are used in a wide array of medical situations, the population at risk includes people of all ages and health conditions.

Patients in Hospital Settings

Patients receiving IV therapy in hospitals, including surgical patients, individuals in intensive care units, and those receiving blood transfusions, may have been exposed to the mislabeled devices. In hospitals, microbore extensions are part of the IV setup for many routine and critical treatments.

Outpatient and Ambulatory Infusion Recipients

Patients undergoing outpatient chemotherapy, hydration therapy, antibiotic infusions, or other treatments in infusion centers may also have received therapy using the recalled microbore extensions.

Long‑Term Care and Home Healthcare Patients

Microbore extensions are used in long‑term care facilities and home health settings. Patients receiving home infusion therapy, for hydration, nutritional support, or other medical needs, could have been affected if the mislabeled products were part of their IV system.

Families of Affected Patients

The impact is not limited to the patient alone. Family members and caregivers often bear the emotional, financial, and practical consequences when a loved one suffers unexpected harm from a medical device.

Medical and Legal Responsibilities of Manufacturers and Providers

Medical device manufacturers owe a legal obligation to design, test, label, and distribute products that meet federal safety standards. Under U.S. law, companies that sell medical devices in the United States must comply with stringent requirements set by the FDA. These requirements include accurate labeling, proper quality control, and truthful representations of product features.

A manufacturer’s failure to provide accurate labeling that falsely claims the presence of a safety component can be the basis for legal claims, including:

• Product Liability: Holding the manufacturer accountable for placing an unsafe or misrepresented product into the marketplace.
• Negligence: If a company fails to act with reasonable care in the design, testing, or labeling of a product, and that failure causes harm.
• Failure to Warn: When a company does not adequately inform end users and healthcare providers of known risks associated with a product.
• Strict Liability: In many states, a manufacturer can be held liable simply because the product is defective and caused harm.

Healthcare providers also have a duty to use devices in accordance with their labeled indications and to exercise professional care in identifying unsafe products. However, providers often rely on manufacturers’ representations about product features.

In the case of mislabeled microbore extensions, a patient harmed after receiving care with these devices may pursue a claim against B. Braun for the harm caused by the defect. Hospitals and care facilities may also share responsibility if they failed to remove the recalled products from use once notified.

Steps Patients Should Take After Exposure to a Recalled Device

If you or a loved one received IV therapy that may have involved the recalled B. Braun microbore extension sets, taking certain actions can protect your health and legal rights.

1. Seek Immediate Medical Evaluation

If you have unexplained symptoms following a recent IV procedure — including sudden shortness of breath, chest pain, confusion, weakness, or neurological changes — obtain medical care promptly.

2. Request Medical Records

Ask for copies of procedural notes, device logs, nursing documentation, and any references to the IV equipment used during your treatment.

3. Preserve Evidence

If you have any packaging, product remnants, or medical discharge instructions that mention the microbore extension, maintain these materials.

4. Document Symptoms and Costs

Keep a written account of symptoms, medical treatments, bills, medications, time missed from work, and other related expenses.

5. Speak with a Product Injury Attorney

An attorney can assess whether the recall and your experience may give rise to a legal claim and can guide you in preserving evidence and meeting filing deadlines.

B. Braun Microbore Extension Set Fatal Air Embolism Lawsuit Frequently Asked Questions

What products are affected by the FDA Class I recall?
The recall applies to B. Braun Microbore Extension Sets that were labeled as including an air‑eliminating filter but do not contain that safety feature.

Why is this recall significant?
Because the missing air‑eliminating component increases the risk of air entering the bloodstream during IV therapy, which can cause a fatal air embolism.

What is a Class I recall?
A Class I recall is the FDA’s most serious type of recall, issued when there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Has anyone been injured by this defect?
As of the recall notice, B. Braun has reported no injuries. However, the risk of harm is severe enough that the FDA required immediate action.

What should healthcare providers do now?
Healthcare facilities must quarantine all affected inventory, stop use immediately, and return the products to B. Braun according to the recall instructions.

Can patients still have been harmed even if the recall happened quickly?
Yes. Patients who received IV therapy before the recall may have been exposed to the mislabeled products.

What symptoms might indicate an air embolism?
Symptoms may include sudden respiratory distress, chest pain, confusion, neurological changes, seizure, or sudden collapse.

Do I need an attorney if I was harmed?
Yes. If you suffered harm after receiving care involving the recalled device, a lawyer can help you pursue compensation for medical costs and other losses.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one received IV therapy involving a recalled B. Braun Microbore Extension Set and suffered complications, you may be entitled to compensation. Parker Waichman LLP is a national personal injury law firm currently handling claims involving dangerous medical devices. Our attorneys can evaluate your case at no cost and explain your legal options.

Call 1‑800‑YOUR‑LAWYER (1‑800‑968‑7529) for your free consultation today. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.