On May 24, 2019, the United States Food and Drug Administration (FDA) issued a class I recall of medical devices used in intracranial medical procedures to address fluid and pressure in the brain. The class I recall, which is the most serious recall available, comes six weeks after the manufacturer of the affected medical devices, Integra LifeSciences, voluntarily issued a recall of the LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. A class I recall is one that involves a drug or medical device that poses a serious risk of harm or death to patients.
The recalled Integra medical devices are used in procedures to drain cerebrospinal fluid and monitor pressure in the brain. These products are also often used to address infected CSF shunts, which are used to treat hydrocephalus, a condition in which excess cerebrospinal fluid builds up in the brain, creating pressure and swelling. Hydrocephalus is also commonly referred to as “water on the brain.”
The Defective Nature of the Integra Intracranial Medical Devices Has Caused Serious Injuries
According to the FDA’s class I recall notification, Integra received multiple complaints regarding failed components of the LimiTorr and MoniTorr devices. Examples of such complaints include, but may not be limited to, the following:
- Piece breaking off at connection point;
- Broken manifold-stopcock;
- Stopcock problem;
- The connection where the external transducer is attached to the transducer holder bracket has broken off; and
- Transducer attachment on the LimiTorr and MoniTorr devices have cracked and were leaking cerebrospinal fluid.
Each of the above-listed device defects has the potential to cause serious injuries. So far, multiple serious injuries have been reported involving infection and CSF leakage (over-drainage). Patients are at risk of sustaining a variety of injuries that include the following:
- Infection (meningitis or ventriculitis);
- Over-drainage leading to subdural hematoma;
- Over-drainage leading to shifting of brain tissue (herniation);
- Backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity (pneumocephalus); and
With many medical devices (such as knee replacements or stents), patients have an understanding of the brand and type of medical device being used. However, with intracranial procedures, patients may not be aware of what specific brand of device is used during the procedure. Many medical devices are implants, while others are tools used to assist in a variety of medical procedures.
Because it may not be clear to patients whether a recalled Integra medical device was used during a procedure, patients who have sustained any injuries identified in the FDA’s recall notice should consult with their doctors to find out whether an Integra device was used in a procedure. If so, a patient’s injuries may be linked to device failure.
Contact Parker Waichman LLP Today to Schedule Your Free Consultation
If you or a loved one has suffered an injury after undergoing an intracranial procedure that you believe involved the use of recalled Integra LifeSciences intracranial medical devices, you should consider speaking with a Defective Medical Device Lawyer about your situation. The Personal Injury and Defective Medical Device Lawyers of Parker Waichman LLP handle a wide variety of injury cases regularly. Allow our legal team to provide you with a thorough evaluation of your potential legal claim. To schedule your free consultation, contact Parker Waichman LLP today by calling 1-800-YOUR-LAWYER (1-800-968-7529).
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