FDA Announces Recall of Inari Medical Catheter
The FDA recently announced a Class I recall of Inari Medical’s ClotTriever XL catheter after reports linked it to six deaths and four injuries. Because of the serious potential complications with the device, patients and providers who use the ClotTriever XL should review the potential risks and new instructions that the FDA released. Those who have already suffered injuries from this device should reach out to an attorney to learn their options for pursuing compensation.
Reports about the ClotTriever XL
Cardiovascular Business reports, “The news comes after the FDA received several reports of ‘serious adverse events’ due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.” The statements suggest that additional adverse events may come to light.
The FDA has issued a correction for Inari Medical’s ClotTriever XL catheter, updating the device’s instructions. The recall emphasizes that the catheter may become entrapped or cause vascular damage, potentially leading to severe outcomes and harm. The updated guidance includes warnings about specific situations where providers should not use the device. The recall affects certain lot numbers but does not require customers to return the products.
What are the affected products?
The affected catheters are as follows:
- Product Names: ClotTriever XL Catheter, 30mm
- Unique Device Identifier (UDI)/Model: 00850291007277/41-102
- Lots: All devices and all lot numbers with labeled dates prior to August 1, 2024
Customers must follow updated instructions
Per Cardiovascular Business:
This is a Class I recall, which means the FDA believes using the device could lead to serious injuries or death. However, unlike many product recalls announced by the FDA, this does not require customers to return the devices or discontinue use. Instead, Inari Medical has published updated instructions for use (IFU) that include additional warnings.
These IFUs include:
- Users should avoid pulling the ClotTriever XL “caudal to cranial” through the upper extremity or jugular vein access.
- Users should ensure the device is “slowly retracted distally away from the heart” while tracking position and visualization under fluoroscopy.
- Recommended use of a device that entraps clots to minimize the risk of embolization of blood clots.
- Sequentially remove portions of the thrombus to avoid removal of the entire clot in one pass.
- Not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material. Ensure you identify patients with these lesion types.
The IFU also notes that the device is contraindicated in patients with suspected tumor thrombus.
How can your Richmond personal injury attorneys help?
If you experienced harm because of Inari Medical’s ClotTriever XL catheter, the Richmond personal injury attorneys at Phelan Petty Injury Lawyers can provide crucial legal support. We will investigate whether the device defect caused your injuries, gather evidence, and consult with medical experts to build a strong case. We can also help determine if you are eligible to join any class action lawsuits or file a product liability claim against the manufacturer. By handling all legal aspects, including negotiations with the manufacturer and insurers, we work to secure maximum compensation for your injuries, medical bills, lost income, and pain and suffering.
In cases involving medical devices, our experienced attorneys develop sophisticated litigation strategies, including seeking out specialized experts who can prove that the device was defective or that there was a failure to warn about risks. We aim to hold the responsible parties accountable and provide you with the justice and compensation you deserve.
If Inari Medical’s ClotTriever XL catheter has harmed you or a loved one, do not wait to seek justice. The experienced Richmond personal injury attorneys at Phelan Petty Injury Lawyers are here to fight for your rights and secure the compensation you deserve. We understand the complexities of medical device claims and will work tirelessly to hold the responsible parties accountable. Contact us today for a free consultation, and let us help you navigate this challenging time. Your health and recovery are our top priority. To schedule a meeting with a Richmond-based personal injury attorney, simply call our offices or fill out our contact form. We serve clients throughout Virginia.
Since 2004, Jonathan Petty has applied the deep knowledge and experience he gained working on the defense side of litigation to represent ordinary people injured by car accidents and truck accidents, medical malpractice, and defective products in Virginia. He has successfully tried medical malpractice and personal injury cases to verdict in courts throughout Virginia, and he has handled cases on behalf of both plaintiffs and defendants in state and federal courts across the country.