AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Recall Insight

This FDA Devices action (record #Z-1159-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on December 19, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Marlborough, MA. Federal records indicate 39 units units are affected.

The documented reason for this recall is: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new … Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungar…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.