Nadrich Accident Injury Lawyers is investigating claims on behalf of patients who suffered serious injuries during implantation of a Boston Scientific AXIOS Stent, as well as on behalf of families who lost loved ones due to something going wrong during the implantation of an AXIOS Stent.
The Boston Scientific AXIOS Stent and Electrocautery Enhanced Delivery System has been recalled by the U.S. Food & Drug Administration because of increased reports of stent expansion and deployment issues.
The FDA has reported 167 serious injuries and three deaths associated with issues related to the AXIOS stent and delivery system.
The issue does not affect successfully implanted AXIOS stents.
Who May Qualify for an AXIOS Stent Lawsuit?
You may qualify to file a civil lawsuit seeking financial compensation for medical bills, lost wages, pain, suffering, wrongful death and more if you or a loved one:
- Was injured during AXIOS stent placement
- Required additional procedures due to a failure to deploy one of the affected devices
- Died following complications linked to one of the affected products
Call our experienced defective medical device lawyers today for a FREE consultation at (800) 718-4658 or contact us if you or a loved one was injured or killed by a complication during the implantation of an AXIOS Stent.
No upfront fees. We only get paid if we recover compensation for you.
Table of Contents
- Why Did the FDA Issue an AXIOS Stent Warning?
- Which AXIOS Stent Models Were Recalled?
- How Much Is a Boston Scientific Stent Injury Lawsuit Worth?
- FAQs
- When to Contact an AXIOS Stent Injury Attorney
Why Did the FDA Issue an AXIOS Stent Warning?
Certain AXIOS stents have increased reports of issues with stent deployment and expansion, which may prolong procedures and require additional interventions.
These incidents have triggered a potentially major Class I recall, indicating the most serious type of recall as defined by the FDA, and that further distribution of the devices should immediately cease.
Boston Scientific Corporation has issued a letter to affected customers recommending certain AXIOS stents and electrocautery enhanced delivery systems be removed from use or sale.
The outer sheath distal black tip of the AXIOS stent can detach from the device, preventing proper expansion and leading to potential complications.
Deployment and expansion failures of the AXIOS stent have been reported during endoscopic ultrasound-guided procedures.
In emergency situations, incorrectly deployed stents may require invasive surgical interventions to remove and repair damage.
Healthcare professionals are advised to cease the use of affected AXIOS products and return them to the manufacturer.
The FDA issued a warning that the problems with the AXIOS stent occur during placement and do not affect stents that have already been successfully implanted.
Injuries and Deaths Linked to AXIOS Stent Deployment Failures
At least 167 serious injuries and three deaths have been linked to specific AXIOS device models due to deployment or expansion issues.
Because of this, Boston Scientific has issued a letter to healthcare professionals recommending the immediate cessation of use and distribution of affected AXIOS devices.
Some of the deaths occurred in patients with limited treatment options due to palliative care or altered anatomy.
The FDA issued a warning and recalled the devices due to the severity of reported outcomes.
The issues with the devices can lead to:
- Tissue damage, infection, bleeding or organ injury
- Life-threatening complications such as sepsis
Which AXIOS Stent Models Were Recalled?
The following devices have been recalled by the FDA after adverse events and patient complications were reported:
- AXIOS Stent And Electrocautery-Enhanced Delivery System – 20mm X 10mm, UPN M00553660
- AXIOS Stent And Electrocautery-Enhanced Delivery System – 6mm X 8mm, UPN M00553680
- *HOT AXIOS Stent And Electrocautery-Enhanced Delivery System – 20mm X 10mm, UPN M00553560
- HOT AXIOS Stent And Electrocautery-Enhanced Delivery System – 6mm X 8mm, UPN M00553520
- *HOT AXIOS Stent And Electrocautery-Enhanced Delivery System – 8mm X 8mm, UPN M00553530
- AXIOS Stent And Electrocautery-Enhanced Delivery System – 8mm x 8mm, UPN M00553690
How Much Is a Boston Scientific Stent Injury Lawsuit Worth?
The value of your case will depend on the specific damages you have incurred due to your complications.
Our law firm can help you recover financial compensation for numerous damages, including:
Medical Bills
We can help you recover compensation for all past and future medical bills related to your complications, including the costs of ER visits, hospital stays, surgeries, medical treatments, medications, therapy, rehabilitation and more.
So, if you needed additional procedures because something went wrong during implantation of a stent, we can help you recover compensation to pay for those procedures.
If you will need additional treatment in the future to deal with your complications, we can help you recover compensation to pay for those treatments as well.
Lost Wages
Our firm can help you recover compensation for any wages you were unable to earn due to your complications.
So, if your complications left you too injured or sick to work for a while, we can help you recover compensation for those hours of work you missed.
If you needed to take some time off from work after your surgery to attend medical appointments, we can help you recover money to compensate you for those missed hours of work as well.
Loss of Earning Capacity
We can help you recover money to compensate you for any loss or reduction of your earning capacity resulting from a disability caused by your complications.
In other words, if your complications have left you with a long-term disability, we can help you recover compensation for the impact that has on your earning potential.
Pain and Suffering
Our firm can help you recover financial compensation for any physical pain, mental suffering, emotional distress and lost quality of life resulting from your complications.
Wrongful Death
If you lost a loved one due to complications resulting from an AXIOS Stent, our experienced wrongful death lawyers can help you recover financial compensation for:
- The loss of your loved one’s love, companionship, income, household services and spousal benefits
- Funeral and burial costs
- The medical bills your loved one incurred before passing
- The pain and suffering your loved one endured before passing
FAQs
Was the AXIOS Stent Recalled?
Yes.
The FDA has reported that certain AXIOS Stent and Electrocautery Enhanced Delivery Systems have increased reports of issues with stent deployment and expansion.
First, the FDA issued an early safety alert on January 16, 2026, regarding the AXIOS stent as a potentially high-risk medical device.
Then, on February 5, a class 1 device recall regarding the stent was posted to the FDA website.
Does the AXIOS Stent Problem Affect Implanted Devices?
No. The AXIOS stent deployment issues occur at the time of delivery and do not affect successfully implanted stents.
What Symptoms May Signal an AXIOS Stent Complication?
Symptoms which may signal a complication during the implantation of an AXIOS Stent include:
- Signs of infection or sepsis
- Internal bleeding or organ injury
- Need for emergency surgery following placement
It is important to note that the issues reported with these devices do not affect stents which have been successfully implanted.
How Long Do I Have to File an AXIOS Stent Lawsuit?
There is a time limit to file your AXIOS Stent lawsuit. This time limit is known as a statute of limitations and will depend upon the specific state involved.
For example, in California, the time limit is typically two years from the date you became aware that you were injured by the AXIOS Stent.
However, there are exceptions to this time limit, and while some lengthen it, others shorten it, so it’s important to contact a lawyer today if you’ve suffered complications due to an AXIOS Stent.
Calling a lawyer today will give them as much time as possible to build a strong case for you, make sure all paperwork gets filed in time, and ensure that evidence can be promptly preserved.
When to Contact an AXIOS Stent Injury Attorney
Call us today for a FREE consultation at (800) 718-4658 or contact us if you were injured during the placement of an AXIOS Stent or if you lost a loved one due to complications linked with an AXIOS Stent.
Why Clients Choose Nadrich Accident Injury Lawyers
- We have handled defective medical device claims since 1990.
- Our team provides responsive service and 24/7 availability.
- We provide clients with frequent case updates.
- Our team provides free, no-obligation consultations.
- We are contingency fee lawyers, meaning no upfront fees or out-of-pocket fees are charged, no fee is charged until we win your case, and our only fee is a percentage of any compensation we recover.
- Our team is not afraid to go to trial, so we will not settle for less when negotiating with insurers and defendants.
Call us today for a FREE consultation at (800) 718-4658.
