Medline Heart Surgery Procedure Kit Injury and Wrongful Death Lawsuit Lawyers

Nationwide Legal Representation for Patients Harmed by Recalled Medline Heart Surgery Kits Containing Defective Medtronic Aortic Root Cannulas

The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most urgent classification, affecting heart surgery procedure kits distributed by Medline Industries. These surgical kits, used in critical open-heart procedures, contain aortic root cannulas manufactured by Medtronic. These cannulas are now known to carry a dangerous defect—excess material inside the male luer, which can obstruct fluid flow and lead to devastating surgical outcomes.

Although the FDA reports no deaths or injuries to date, the risks identified by this recall are among the most serious in any surgical setting. The defective cannulas have been linked to:

• Delayed or interrupted surgical procedures
• Neurological impairment
• Stroke
• Air embolism
• Cardiac trauma
• Death

For patients undergoing coronary artery bypass grafting (CABG) and other open-heart surgeries, any defect in the surgical equipment used during cardiopulmonary bypass is a threat to life and recovery. If you or your loved one experienced complications during heart surgery involving a Medline procedure kit, you may be eligible to file an injury or wrongful death lawsuit.

The Root of the Problem: Defective Medtronic Aortic Root Cannulas

At the center of this recall is a vital device: the aortic root cannula. This tool is inserted during open-heart procedures to help manage blood flow while a patient is connected to a heart-lung machine. It may also be used to evacuate air from the aorta after bypass procedures. The cannula is only used for several hours but is crucial during this window.

Medtronic’s recall, initially announced in early February 2025, identified excess manufacturing material in the male luer of several cannula models. This defect can impair blood flow or prevent proper function, putting patients at extreme risk when seconds count.

Medtronic’s recalled products include:

• DLP Aortic Root Cannula – CFN 11012 and 11014
• MiAR Cannula – CFR 11012L and 11014L
• DLP Aortic Root Cannula with Vent Line – CFN 21012 and 21014

Although Medtronic’s standalone recall included more than 316,000 devices globally, the risk became even more widespread once Medline identified that its pre-assembled surgical kits also contained the defective cannulas. These kits are commonly used by hospitals for efficiency and consistency during cardiac procedures.

Medline Procedure Kits Involved in the Recall

Medline’s recall, issued on February 21, 2025, expands the risk to additional patients and medical facilities. According to the FDA, at least 3,345 Medline kits are affected. The risk is compounded because these kits were distributed directly to hospitals and used in routine open-heart procedures.

Affected Medline heart surgery kits include:

• CABG OPNHRT Salem HSP
• Cardiac CABG
• Cardiac Pack
• Danielson AC Pack
• Heart Basin Pack-LF
• Karas OH Component Pack
• Open Heart Adult Part 1 CDS
• Open Heart B Pack-LF
• Open Heart Pack
• Zeeshan Open Heart
• TOL Dr. Riordan Pack
• CPB Adjunct Pack
• Crescenzo Pack
• PK Cust CV A&B Cabrini CO
• TOL Dr. Moront Pack

In some cases, surgical teams may not have been aware that a defective cannula was included in their kits until after the procedure began. The inclusion of a warning sticker does not negate the fact that these dangerous components were widely distributed, often without the knowledge of patients or their families.

Known Risks and Consequences of the Defective Cannula

Heart surgery is inherently risky, but using defective surgical components greatly increases the chances of complications. When excess material obstructs the flow path in an aortic root cannula, it can:

• Slow or block perfusion during cardiopulmonary bypass, reducing oxygen delivery to vital organs
• Cause blood clots or embolisms, increasing the risk of stroke or cardiac arrest
• Interrupt surgical flow, forcing the surgical team to pause or replace instruments mid-procedure
• Introduce foreign material, potentially leading to infections, inflammation, or vascular trauma

These risks can result in devastating complications such as:

• Cognitive decline or brain injury
• Organ failure
• Extended hospitalization or ICU stays
• Unplanned reoperation
• Permanent disability
• Wrongful death

If your loved one suffered a stroke, lost brain function, or died following a procedure using a Medline surgical kit, this recall may be the reason—and your family deserves to know your legal rights.

Who May Qualify to File a Lawsuit

Our firm is currently reviewing cases involving individuals harmed by Medline heart surgery kits containing Medtronic’s recalled cannulas. You may qualify to file a lawsuit if:

• You or a loved one underwent heart surgery between February 2023 and the present
• The hospital used Medline heart surgery kits as part of the procedure
• The patient suffered a stroke, cardiac complication, or unexpected adverse event during or after surgery
• The adverse event was unexplained or attributed to “technical difficulty” or “instrument failure” at the time
• A loved one died unexpectedly during or shortly after a heart bypass procedure

Even if you are unsure which surgical kit was used, medical records and supply logs from the hospital can be reviewed by our legal team. These records often list product batch numbers and supply kit identifiers that can help determine if a recalled device was involved.

How to File a Medline Heart Surgery Kit Lawsuit

Filing a lawsuit against a medical manufacturer or supplier may feel overwhelming—especially after a traumatic surgical complication or the loss of a loved one. Our law firm handles all aspects of the legal process, including:

1. Reviewing Your Medical Records: We will obtain surgical documentation and procedure notes from the hospital to verify if the recalled kit or cannula was used.
2. Investigating the Complication: Our legal and medical experts will analyze how the defect may have contributed to injuries, surgical delays, or adverse outcomes.
3. Filing a Claim: We will file a lawsuit against Medline, Medtronic, or any other liable party seeking damages for medical costs, lost wages, pain and suffering, long-term care, and wrongful death.
4. Pursuing Financial Compensation: Your claim may include compensation for future medical care, rehabilitation, permanent injury, emotional distress, funeral costs, and more.

We do not charge legal fees unless we recover money for you.

Parker Waichman LLP: Fighting for Victims of Medical Device Defects Nationwide

At Parker Waichman LLP, we represent patients and families nationwide who have been harmed by unsafe medical products and surgical tools. The recall of Medline heart surgery kits containing Medtronic aortic root cannulas presents a clear and preventable risk. When patients suffer as a result of these failures, the manufacturers and distributors must be held accountable.

We are currently accepting injury and wrongful death cases related to this Class I recall. Our legal team will carefully review your case, identify all responsible parties, and work tirelessly to secure the compensation you deserve.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one experienced complications, stroke, or death during heart surgery involving a Medline procedure kit, legal action may help you secure justice and financial relief. The inclusion of defective Medtronic aortic root cannulas in these kits puts lives at risk, and your family deserves answers.

Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) for a free, confidential consultation. We are investigating injury and wrongful death claims nationwide. There are no legal fees unless we win your case.Don’t wait—learn your rights today and take the first step toward holding those responsible accountable.