Integra LifeSciences CSF Drainage and ICP Monitoring System Lawsuit Lawyers
A recent FDA public health notification announcing a Class I recall of two medical devices manufactured by Integra LifeSciences used to drain cerebral spinal fluid (CSF) and monitor and reduce intracranial pressure (ICP) has raised concerns among medical providers and patients. A Class I recall is considered the most severe type of recall available, and the FDA only issues a Class I recall when a drug or medical device poses a serious risk of injury or death to patients. According to the FDA, certain components of these Integra ICP devices can break off or fail to work as intended. The FDA has received reports of patient injuries, but so far, there have been no reported deaths.
If you or a loved one has sustained injuries following a medical procedure involving the use of Integra LifeSciences CSF drainage and ICF monitoring systems, you may be entitled to compensation. However, you first must speak with a qualified defective medical device lawyer to determine if you have grounds to seek legal action. Because time is limited to file a claim, it’s crucial to speak with a lawyer right away. At Parker Waichman LLP, our experienced attorneys can give you a free consultation to help you learn about your legal rights.
What Are Integra LifeSciences CSF Drainage and ICF Monitoring Systems?
Integra LifeSciences manufactures medical devices used to treat serious brain conditions that are often life-threatening. The LimiTorr Volume Limiting Cerebrospinal Spinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems are used to monitor the pressure in a patient’s brain and to drain CSF from the brain to reduce intracranial pressure. When the pressure inside the skull is too high, it can pose a risk of injury or death.
Patients may experience an increase in CSF or ICP when they have infected CSF shunt systems, which are used to drain CSF from the brain to other parts of the body. Such shunt systems are often used to treat hydrocephalus, a condition that results from a buildup of CSF and ICP. These patients rely on drainage and monitoring systems like an Integra ICP monitor to ensure that infections and a buildup of CSF and ICP do not cause further damage or even death.
Which Integra LifeSciences CSF Drainage and ICF Monitoring Systems Have Been Recalled?
The Integra LifeSciences recall, issued on April 8, 2019, included multiple versions of the LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. More than 24,500 of these devices were manufactured and distributed between March 1, 2017, and March 31, 2019, and all of these have been recalled. Specific products include:
|Catalog Number||Catalog Description||UDI|
|10-100||CSF Drainage System w/Patient Line One Way Valve||10381780070825|
|10-102||CSF Drainage System w/Patient Line One Way Valve w||10381780070832|
|10-110||CSF Drainage System used with Pole Mount System||10381780070849|
|10-140||CSF Drainage System w/Vinyl Measuring Strip||10381780070856|
|10-150||CSF Drainage System Simple Bag and Line||10381780070887|
|10-150||CSF Drainage System w/o Manifold Stopcock||10381780070894|
|INS-1100||CSF Drainage System used with Pole Mount System||10381780071037|
|INS-9020||LimiTorr Volume Limiting EVD 20 ML||10381780071105|
|INS- 9020SP1||LimiTorr Volume Limiting EVD 20ML||10381780071112|
|INS- 9020SP1||LimiTorr Volume Limiting EVD 30 ML||10381780071129|
|INS- 9030SP1||LimiTorr Volume Limiting EVD 30 ML||10381780071136|
|SP0017||Special EVD 10-110 w/o Y Site Latex Free Sites||10381780071891|
|SP0042||Special EVD 10-100 w/o Y Site||10381780071914|
|SP0090||Special EVD 10-110 w/o Y Site||10381780071945|
|SP0164||Special EVD 10-140 w/Y Site & Stopcock Reverse||10381780071945|
|SP0236||INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI||10381780072560|
Why Has the FDA Issued a Class I Recall of Integra LifeSciences CSF Drainage and ICF Monitoring Systems?
The specific reasons why Integra LifeSciences issued a recall of its LimiTorr and MoniTorr devices and why the FDA has issued the recall as a Class I notice include these reported complaints:
- Pieces breaking off at a connection point
- Broken manifold-stopcock
- Broken connection where the external transducer is attached to the transducer holder bracket
- Cracked transducer attachment causing leaking of CSF
According to the FDA’s recall notification, breakage happens when there is overbending of the stopcock, which is most often related to using the LimiTorr or MoniTorr devices in conjunction with a Fluid Filled Transducer.
Such defects and device failures may result in:
- Infection (such as meningitis or ventriculitis)
- Overdrainage, leading to subdural hematoma or shifting of brain tissue (herniation)
- Backflow of air, leading to a condition in which air or gas is trapped within the intracranial cavity
Frequently Asked Questions About Recalled Integra LifeSciences Medical Devices and ICP Monitor Lawsuits
Is a CSF Leak Serious?
Yes. A CSF leak is a serious condition that arises when the membrane containing the fluid around the brain and spinal cord is damaged. When this happens, it can cause meningitis, headaches, and seizures.
Can a CSF Leak Fix Itself?
A CSF leak does have the ability to heal on its own, but it’s recommended to see a medical professional due to the potential risks.
What Are CSF Leak Symptoms?
Common symptoms of a CSF leak include positional headaches, neck pain/stiffness, nausea, and vomiting.
What Happens if a CSF Leak Is Not Treated?
If a CSF leak goes untreated, it can lead to complications such as meningitis, stroke or a brain infection.
How Do You Monitor ICP With an EVD Drain?
An external ventricular drainage (EVD) system places a catheter in the ventricle of the brain that is capable of draining excess cerebral spinal fluid in order to reduce pressure. By doing this, medical professionals can monitor and regulate the patient’s ICP by controlling the amount of fluid.
How Is ICP Measured?
ICP is measured either by inserting a catheter into the ventricle of the brain or by placing a tiny, hollow device known as a bolt into the area between the brain and skull.
What Happens if You Drain Too Much CSF?
If too much CSF is drained, a headache will likely develop due to lowered pressure in the skull, which can lead to a condition known as intracranial hypotension.
How Do I Know if My Injuries Are Related to the Integra LifeSciences CSF Drainage and ICF Monitoring Systems?
If you believe you may have sustained injuries related to the use of these recalled devices, a qualified lawyer can investigate your case to determine whether you might have grounds for a lawsuit. Your attorney will obtain your medical records, which should document what procedure(s) you underwent and what device(s), if any, were used.
Can I Receive Compensation for My Injuries Without Filing a Lawsuit?
Maybe. In some defective medical device cases, defendants may aim to resolve claims without going to court to minimize the cost of litigation and the negative consequences associated with widespread lawsuits. However, many drug and medical device companies fight allegations in court to the fullest extent. In such cases, injured plaintiffs will likely have to file lawsuits to get compensation for their suffering. When possible, your attorney may try to secure a settlement without going to court; this option is often more favorable to plaintiffs who do not wish to take the risk of going to trial, as trials are always unpredictable.
Should I File a CSF Leak Lawsuit?
If you think you might have a CSF leak lawsuit, you should speak with an attorney who can evaluate your case and help you determine whether to sue. These cases can be complex, so if you’re considering legal action due to harm from an improperly treated CSF leak, you’ll want a knowledgeable and experienced lawyer to help protect your legal rights.
If I Decide to File a Lawsuit, Where Will My Lawsuit Be Filed?
If you proceed with filing a lawsuit, depending on where the defendant is located, your case may be filed in federal court or state court. Typically, a lawsuit is filed in the jurisdiction in which the plaintiff is injured or where the plaintiff lives. In some cases, a lawsuit may be filed in a defendant’s home state. If the defendant and plaintiff are not located in the same state, the case will likely be filed in federal court.
Are There Limits on How Much Compensation I Can Receive for My Injuries?
It depends. Some states place caps on damages for pain and suffering, meaning that the total amount of compensation you can receive may be limited by state law. When you work with an attorney at Parker Waichman, we’ll work to maximize the amount of compensation you receive.
How Much Time Do I Have to Move Forward With Filing a Lawsuit?
Each state has its own statute of limitations that determines how long you have to file a lawsuit. Some states only allow one or two years from the date of injury to file a lawsuit, while other states provide a four- or five-year window. Additionally, some states allow injured plaintiffs to extend the limitation period to begin when the plaintiff becomes aware that their injuries were caused by a defective product.
Why Should I Choose Parker Waichman to Handle My Claim?
The defective medical device lawyers at Parker Waichman have substantial experience handling complex legal claims involving injuries to innocent individuals. Our law firm has a good understanding of the science behind Integra ICP monitor defects, and we’re capable of handling the most complicated types of litigation on behalf of our clients. Our nationally recognized trial lawyers are adept at securing jury awards and settlements for injury victims, to the tune of more than $2 billion and counting. We’ve also earned numerous honors from our peers in the legal community, including the highest possible peer-review rating from Martindale-Hubbell and a 9.8 out of 10 rating from AVVO.
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If you think you might have a CSF leak lawsuit, call Parker Waichman today. We’ll give you a free case evaluation to help you learn about your legal rights and decide on your next steps. If our firm is able to represent you or your loved one, our defective medical device attorneys will thoroughly investigate your case at no charge, and our firm will take your case on a contingency-fee basis. In other words, our recovery is contingent on yours: If you don’t receive compensation, neither do we.
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