3 Dead, 167 Seriously Injured! Boston Scientific's Star Product Release Alert

On January 16, 2026, the U.S. Food and Drug Administration (FDA) announced that Boston Scientific has issued a notification to customers advising them to: Immediately discontinue use and return specific lots of AXIOS™ Stent and Electrocautery Enhanced Delivery System.

This product is currentlyAmerica's only A stent system approved for endoscopic ultrasound-guided drainage of symptomatic pancreatic pseudocysts and walled-off necrosis, with some models also suitable for gallbladder drainage in patients with acute cholecystitis.

The system integrates an electrocautery catheter with a stent, aiming for a single, no-instrument-exchange surgical procedure.

Source: FDA

Boston Scientific has observed an increase in reports of difficulty with stent deployment and expansion during delivery.This issue may prolong the procedure time and require stent replacement; if the stent cannot be expanded, additional endoscopic or surgical intervention may be necessary.

As of December 23, 2025, the company has received 167 reports of serious injuries and 3 reports of deaths related to this issue.

Official announcements disclose that the following lots of AXIOS stents and electrocautery-enhanced delivery systems must be immediately discontinued and quarantined:

Boston Scientific issued a letter to affected customers on December 19th, requesting the following:

Stop using, distributing, or selling the affected devices immediately. Remove them from inventory and isolate them until they are returned.

Post conspicuous notices in the relevant areas to ensure all operators are aware.

Please forward this notice to all relevant healthcare personnel within your institution and to other institutions that may have received this product.

Distributors must ensure that notifications are passed on to the end-users.

Use the AXIOS stent strictly according to the product instructions.

This issue only occurs during stent implantation and does not affect successfully implanted stents. Affected patients should continue standard treatment and follow-up.

FDA continues to evaluate this high-risk medical device issue and will keep the public informed as new information becomes available. Stakeholders are encouraged to monitor the official FDA website for the latest updates.