You may be eligible to file a Tylenol Autism ADHD Lawsuit / Acetaminophen Autism ADHD Claim if you or a loved one used Tylenol and/ or Acetaminophen during pregnancy, and your child was subsequently diagnosed with ADHD or Autism Spectrum Disorder.
Over 140,000 Exactech hip, knee and ankle implants have been recalled due to packaging errors that can lead to the breakdown of parts vital to the device’s function.
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Over one million people, who were present at Camp Lejeune (North Carolina) between 1953 and 1987, may have been exposed to toxic substances in the water.
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If you have been exposed to Paraquat and diagnosed with Parkinson’s disease may be eligible to pursue compensation, and entitled to participate in the paraquat lawsuit.
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Our firm is about people. That is our motto and that will always be our reality.
At TorHoerman Law, we believe that if we continue to focus on the people that we represent, and continue to be true to the people that we are – justice will always be served.
Medtronic issued a recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology in February of 2020, citing risks that the systems can fracture while being placed inside of patients.
These fractured pieces can stay inside of patients’ bloodstreams leading to worsened conditions and other serious adverse health effects such as blocked blood vessels, stroke, and death.
The U.S. Food and Drug Administration labeled the decision a Class I Recall, the most serious of FDA recalls.
If you or a loved one received a Medtronic Pipeline Flex Embolization Device and subsequently suffered serious health injury associated with the device, you may be eligible to participate in a Medtronic Pipeline Flex Embolization Device lawsuit.
Contact an experienced Medtronic Pipeline Flex Embolization Device lawyer from TorHoerman Law to discuss your legal options, or get an instant case evaluation online now.
According to Medwatch, the FDA Safety Information and Adverse Event Reporting Program, there have been 50 medical device reports of Medtronic Pipeline Flex Systems fracturing from November 1, 2019, to March 1, 2020.
Of the reports, there have been 10 injuries and 1 death.
Patients who already have a Pipeline Flex Embolization Device successfully implanted are not at increased risk.
TorHoerman Law is exploring possible Pipeline Flex Embolization Device lawsuits.
If you or a loved one suffered from a Pipeline Embolization Device injury or death, contact us to learn more about your potential case.
What is a Pipeline Flex Embolization Device?
A Pipeline Flex Embolization Device, or “Pipeline Flex,” is a permanent stent used to treat brain aneurysms.
The Pipeline Flex stent is made up of braided platinum, tungsten, and cobalt-chromium-nickel alloy wires.
A guidewire-based delivery system is used to implant the device inside of patients.
Pipeline Flex Embolization Surgery
Pipeline Flex embolization surgery can treat brain aneurysms for patients who are 22 years and older.
The device and surgery are used to treat brain aneurysms including:
Small or Medium Wide-Neck Aneurysms: neck width 4 mm or wider, dome-to-neck ratio 2 or less
Saccular or Fusiform Aneurysms: spindle-shaped, elongated aneurysms that involve the entire vessel
Internal Carotid Artery Aneurysms: vessel diameter from 2 – 5 mm
Large Wide-Neck Aneurysms: in certain internal carotid artery regions
Pipeline Flex surgery has proven to be an effective brain aneurysm treatment.
In a clinical study of 134 patients treated with a Pipeline Flex device, 79.98 percent of them had complete occlusion of their aneurysm within a one-year period.
None of these patients required re-treatment or restenosis.
Pipeline Flex Embolization Recall
The Medtronic Pipeline Flex Embolization Device recall has been in effect as of February 14, 2020.
It is a Class I Recall, meaning the use of the devices could lead to serious injuries or death.
Per the FDA Website:
Recalled Product:
Pipeline Flex Embolization Device (Available in the US)
Pipeline Flex Embolization Device with Shield Technology (Not Available in the US)
Product Codes:
Pipeline Flex Embolization Device:
PED-250-XX
PED-275-XX
PED-300-XX
PED-325-XX
PED-350 -XX
PED-375-XX
PED-400-X
PED-425-XX
PED-450-XX
PED-475-XX
PED-500-XX
Pipeline Flex Embolization Device with Shield Technology:
Medtronic issued an urgent field safety notice regarding its Pipeline Flex Embolization Devices.
The Minnesota-based company warned that the devices could potentially fracture and leave remains inside of patients.
This unintended separation can lead to significant adverse effects such as:
Ischemic stroke
Extended procedure
Intracranial hemorrhaging
Neurological damage
And even death
The company noted in the field safety notice that if a patient already has a successfully implanted embolization device, there is not an increased risk, and those patients can continue with normal treatment.
Medtronic urged any patients affected by the devices’ fracturing to immediately stop using the affected products.
The company said healthcare professionals should remove and quarantine any unused devices and return them to Medtronic.
Medtronic officials said that the affected lot of devices include any with a “use-before” date from on or after October 21, 2022.
The field safety notice said the company has not received complaints about issues from the affected population.
Is the Pipeline Flex Embolization Device FDA approved?
The FDA approved the Pipeline Flex Embolization Device (P100018/S015) on December 14, 2018.
Full information about the product and the basis for its approval can be found in the Summary of Safety and Effectiveness Data (SSED).
However, the FDA issued a Class I Recall (the most serious recall) in February 2020.
Due to risks of the delivery systems fracturing inside of patients, Medtronic recalled its:
Pipeline Flex Embolization Device
Pipeline Flex Embolization Device with Shield Technology
Who is Affected by the Device Recall?
The Medtronic Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology recall were initiated to protect patients and healthcare providers.
There are risks the systems can fracture while providers place the stent inside of patients.
Those who might be affected are:
Healthcare providers using the Pipeline Flex device to treat brain aneurysms
Any patient groups undergoing procedures that involve the Pipeline Flex Embolization Device or Pipeline Flex Embolization Device with Shield Technology
What should Patients and Providers Do?
Medtronic alerted its customers with an Urgent Medical Device Recall Notice regarding the affected Pipeline Flex Devices.
Affected devices include any product manufactured between October 22, 2019, to February 1, 2020, and any devices distributed from November 6, 2019, to February 8, 2020.
The recall included the following instructions:
Do not use any affected devices. Remove and quarantine all unused affected products.
Return the affected products to Medtronic. Medtronic representatives will assist in facilitating the returns if needed. They can also assist in identifying suitable replacement devices.
Complete the Medtronic Customer Confirmation Form and share it with the Medtronic team.
Share the company’s recall notice with all organizations impacted by the affected products.
Be aware that Medtronic has taken all necessary steps to stop the future distribution of the affected products.
Medtronic advised customers with questions to contact Medtronic Quality Assurance at 1-800-633-8766 or rs.nvcomplaints@medtronic.com.
Do your due diligence when seeking legal representation, but do not wait too long to take this initial legal step – the statute of limitations limits the amount of time that you have to take legal action after an injury has occurred.
After hiring a Pipeline Flex Embolization Device lawyer, you should familiarize yourself with the steps of civil litigation, so you know have some idea of the process of a Pipeline Flex Embolization Device lawsuit.
It’s also crucial to gather evidence including any necessary documents, bills, photos, and records.
Your Pipeline Flex Embolization Device lawyer will help you to assess damages and make a claim against the party that holds liabilityfor your losses.
In this case, liability will fall on the manufacturer, Medtronic.
However, depending on the circumstances, other parties could also hold some liability.
Your attorney will work to win you compensationfor your losses either through a pretrial settlement or in a Pipeline Flex Embolization Device lawsuit trial.
Hiring a Pipeline Flex Embolization Device Lawyer
TorHoerman Law is exploring a possible Pipeline Flex Embolization Device lawsuit.
Center for Devices and Radiological Health. “Pipeline Flex Embolization Device – P100018/S015.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/recently-approved-devices/pipeline-flex-embolization-device-p100018s015
FDA Expands Indications for Medtronic’s Pipeline Flex embolization device
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