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Urgent Recall issued for Hemostasis Valve

On March 4, 2016, Vascular Solutions – the maker of the Guardian II hemostasis valve – issued an urgent recall over concerns that a defect in the device can cause serious injury or death to patients on whom the device is used. Doctors and hospitals need to take the devices out of service. According to the Food and Drug Administration (FDA) and the recall notice issued by Vascular Solutions, the low pressure seal of the device is defective and may allow air bubbles to enter and block blood supply to the heart and vessels. This event (called an “air embolism”) is a serious medical event that can result in death. Over 5,000 units have been distributed to medical care providers in over two dozen states, including Pennsylvania.

What is a Hemostasis Valve?

Hemostasis valves are used during catheterization procedures to reduce blood loss in the patient. These valves function as “points of entry” in that they allow medical professionals to insert catheters (or other instruments) into the body. When the instrument is removed, these devices are supposed to “seal” as the instruments are withdrawn. When such a valve does not completely seal, foreign matter such as air bubbles can enter through the valve. Depending on what enters the body and where the valve is located, the results of foreign matter entering the body can be devastating to the patient.

What is an Air Embolism?

An air embolism is, essentially, the presence of an air bubble in the cardiovascular or circulatory system. As the bubble travels throughout the system and depending on the embolism’s size, it may restrict blood flow to certain parts of the body or block blood flow altogether. An embolism that affects blood flow to the heart or brain can result in death to the individual if emergency care and treatment is not administered right away. The symptoms of an air embolism can vary depending on what parts of the body are affected by the bubble. For example, an embolism that is affecting blood flow to the brain would cause signs and symptoms that resemble those of a stroke. In a similar way, an embolism that is blocking or restricting blood flow to the heart would cause signs and symptoms that mimic those of a heart attack.

What Should I Do About the Recall?

Unless they have been specifically informed by their medical care provider(s) that the provider(s) is using this Guardian II device, it is unlikely that patients in Pennsylvania or patients in any of the other identified states will know whether their medical care provider is using this recalled device. Patients should speak with their doctor before any catheterization procedure to determine whether the doctor intends on using this recalled device.

Cohen, Placitella & Roth, P.C. is an experienced Pennsylvania defective medical device law firm helping patients who have been injured or killed by defective devices and their families recover compensation for their losses and expenses. Contact our knowledgeable and compassionate legal team about your medical device-related injuries by calling (866) 236-4230 or by completing our firm’s online form.

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