Inari Medical's ClotTriever XL Catheter and FlowTriever Linked to Injuries and Deaths, Recalled
Inari Medical’s ClotTriever XL catheter is designed to remove clots from large blood vessels.
In July 2024, the company updated the device’s instructions for use after reports of serious adverse events, including device entrapment and pulmonary emboli, leading to patient injuries and deaths.
The FDA classified this action as a Class I recall—the most serious type—due to the potential for severe health consequences, including vessel damage and death.
The recall affects all ClotTriever XL devices with labeled dates prior to August 1, 2024.
The updated ClotTriever XL catheter instructions include specific warnings, such as avoiding pulling the catheter through the jugular vein and ensuring slow retraction away from the heart to prevent advancing clots into the pulmonary arteries.
Additionally, the device is now contraindicated for removing predominantly fibrous, firmly adherent, or calcified material, and in patients with suspected tumor thrombus.
How Have Deaths and Injuries Related to these Products Occurred?
Deaths and injuries linked to Inari Medical’s FlowTriever and ClotTriever catheters have occurred due to a range of device-related complications during clot removal procedures.
These devices, while designed to treat pulmonary embolism and deep vein thrombosis, have been reported to cause severe damage when they malfunction or are improperly used.
Several deaths and injuries have been directly tied to these catheters due to issues such as device misdeployment, vessel perforation, and improper retraction of the device through critical blood vessels.
Key causes of injuries and deaths may include:
- Vessel perforation: The catheter can damage blood vessel walls during clot removal, leading to internal bleeding.
- Device entrapment: Instances where the catheter became lodged in blood vessels, leading to tissue damage and complications.
- Improper retraction: When the device is pulled through the jugular vein too quickly, clots can be dislodged and advance to critical areas such as the pulmonary arteries.
- Device misdeployment: Incorrect placement or functioning of the catheter resulted in harm, including further emboli and complications.
- Fibrous clots or tumor thrombi removal: The device was used on inappropriate material, causing additional strain and risks during the procedure.
- Pulmonary embolism: Clots were unintentionally dislodged and moved into the pulmonary arteries, leading to fatal blockages.
These issues have prompted the recall and revision of safety instructions to prevent further deaths and injuries.
What are Inari Catheter Devices Used For and How Do They Work?
Inari catheter devices, including the FlowTriever and ClotTriever systems, are designed to treat life-threatening blood clots in the veins.
They are primarily used to manage conditions like pulmonary embolism (PE) and deep vein thrombosis (DVT), which occur when blood clots block major vessels in the lungs or legs.
The devices work by physically removing clots from the blood vessels, offering a non-surgical alternative to traditional clot treatments like blood thinners or thrombolytic drugs.
This can provide faster relief for patients who are at risk of serious complications from clot blockages, such as stroke, heart attack, or permanent tissue damage.
The FlowTriever system is designed for removing clots from the pulmonary arteries, while the ClotTriever system targets clots in larger veins, such as the deep veins in the legs.
Both devices use specialized catheter technology, which is inserted through the veins to reach the clot. Once in place, the catheter is expanded to grab and extract the clot from the vessel.
This process helps restore blood flow and can significantly reduce symptoms related to clot blockages.
Although these devices are highly effective for many patients, improper use or defects in the devices have been linked to serious injuries, including vessel damage, internal bleeding, and other complications.
Proper training and following updated safety protocols are essential to reduce the risks associated with these devices.
Do You Qualify for the Inari Catheter Lawsuit?
Inari Medical issued a recall of its FlowTriever and ClotTriever catheters due to manufacturing defects and updated safety concerns.
These devices, linked to serious injuries and deaths, were found to cause complications such as vessel perforation and internal bleeding during clot removal procedures.
As a result, lawsuits are being investigated to seek compensation for those affected by the device’s failures.
If you or a loved one suffered harm from an Inari catheter, you may be eligible to file a lawsuit and seek compensation.
Contact our legal team today to explore your legal options and pursue justice.
Lawyers help individuals throughout the legal process, helping individuals collect evidence and assess damages suffered in their case.
Gathering Evidence for a Lawsuit
Evidence plays a crucial role in proving liability and securing compensation in an Inari Catheter Lawsuit.
Strong documentation of the injuries, the procedures involved, and the use of the device is necessary to demonstrate that the device caused harm.
Without clear and detailed evidence, it becomes difficult to hold the manufacturer accountable for the injuries or deaths related to the catheter.
Possible evidence in a lawsuit could include:
- Medical records: Detailed documentation of the procedure, device use, and any complications or injuries sustained.
- Product identification: Proof that the specific recalled Inari catheter was used, including batch numbers or product labels.
- Injury documentation: Reports from doctors, hospital records, and photographs showing the extent of the harm caused.
- Witness testimony: Statements from medical professionals involved in the procedure or those who witnessed the harm caused by the device.
- Recalls and manufacturer warnings: Evidence of the recall notices, safety alerts, and updates issued by Inari Medical.
- Device malfunction reports: Any reports or complaints filed with the FDA or other regulatory agencies about device failure.
Damages in Defective Medical Device Lawsuits
Damages in defective medical device lawsuits are essential in compensating victims for the harm caused by malfunctioning or dangerous products like the Inari catheter devices.
Damages cover the financial, physical, and emotional tolls experienced due to the injury.
In cases involving severe injuries or death, damages can also include compensation for loss of life, long-term care, and other significant losses.
Potential damages in a lawsuit may include:
- Medical expenses: Costs associated with hospital stays, surgeries, treatments, and rehabilitation.
- Lost wages: Compensation for time missed at work due to injury or recovery.
- Future earnings: Damages for diminished earning capacity if the injury leads to long-term disability or inability to work.
- Pain and suffering: Compensation for the physical pain, emotional distress, and mental anguish caused by the injury.
- Loss of consortium: Damages for the impact the injury has on relationships, including loss of companionship or support.
- Punitive damages: In cases of gross negligence, additional compensation meant to punish the manufacturer for reckless or harmful behavior.
In cases where a loved one has died due to a defective medical device like the Inari catheter, pursuing a wrongful death lawsuit is an option for families.
These lawsuits seek compensation for funeral expenses, the loss of future income, and the emotional suffering caused by the untimely death.
Families can also seek damages for the loss of companionship and support that their loved one would have provided.
TorHoerman Law: Investigating Inari Catheter-Related Injuries and Deaths
The recall of Inari catheter devices highlights the serious risks that defective medical devices pose to patient safety.
These products have been linked to severe injuries, including vessel damage and internal bleeding, and have resulted in multiple deaths.
Such cases emphasize the importance of holding manufacturers accountable when their devices fail, leading to devastating consequences for patients and their families.
If you or a loved one has suffered serious injuries or death due to a defective medical device like the Inari catheter, you may be entitled to compensation—contact us today to discuss your legal options.
