This communication is a medical device early alert. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

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:

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.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

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.

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.