Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

Detected February 26th, 2026

Summary

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.

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What changed

The FDA has identified a Class I recall for Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to problems with stent deployment and expansion during procedures. This issue can lead to prolonged procedures, potential need for device exchange, or surgical intervention for removal and closure. As of December 23, the FDA is aware of 167 serious injuries and three deaths associated with this defect.

Healthcare providers and distributors are instructed to immediately stop using or distributing the affected devices, remove them from inventory, and segregate them for return to Boston Scientific. Patients who have successfully implanted stents should continue to follow standard care protocols, as the issue only pertains to the delivery phase. Failure to comply with recall instructions could result in continued patient harm.

Source document (simplified)

This recall **involves removing certain devices from where they are used or sold.* The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed.*

Affected Product

The FDA is aware that Boston Scientific has issued a letter to affected customers recommending certain stents and electrocautery enhanced delivery systems be removed from where they are used or sold.

Affected devices:

| Device Name | Unique Device Identifier | UPN |
| --- | --- | --- |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729904540 | M00553520 |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729904557 | M00553530 |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729951100 | M00553560 |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729951179 | M00553660 |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 00191506008086 | M00553680 |
| AXIOS Stent and Electrocautery Enhanced Delivery System | 00191506008093 | M00553690 |
Full List of Affected Lots

What to Do

Do not use or distribute affected product. Patients who have been treated with a successfully implanted AXIOS stent should continue to follow standard of care, as the issue only occurs at the time of delivery of the stent.

On December 19, Boston Scientific sent all affected customers a letter recommending the following actions:

Immediately stop further distribution or use of any remaining affected devices. Remove them from your facility’s inventory and segregate them in a secure location until they can be returned to Boston Scientific.
Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.
Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred.
If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level.
If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.
Boston Scientific reminds healthcare professionals that AXIOS Stents should only be used as indicated in Instructions For Use.

Reason for Recall

Boston Scientific stated that certain AXIOS Stent and Electrocautery Enhanced Delivery Systems have increased reports of issues with stent deployment and expansion. This issue occurs at the time of delivery of the stent and does not affect successfully implanted stents.

Difficulty deploying the stent may prolong the procedure so the device may be exchanged for a new one. In cases where the first flange is unable to deploy or expand, additional endoscopic or surgical intervention may be needed to remove the stent and close the puncture site.

As of December 23, Boston Scientific has reported 167 serious injuries, and three deaths associated with this issue.

Device Use

The AXIOS Electrocautery-Enhanced Stent and Delivery System are indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts and/or walled-off necrosis. Certain models may also be used to facilitate drainage of the gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at ComplaintCallCenter@bsci.com.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates

| Date | Actions |
| --- | --- |
| 02/25/2026 | The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. |
| 01/16/2026 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |