HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Recall Z-1036-2025 · Posted 2025-01-29
Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeKNS
Date Initiated2024-12-20
Product Quantity1102 units (OUS)
Reason for Recall
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Firm Action
Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take:
This removal affects only the products listed in Attachment 1.
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.
Contact your local Boston Scientific representative with any questions.
Root Cause
Process control
Distribution Pattern
Nationwide including Puerto Rico Foreign: To be provided
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.