FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
- Recall number
- Z-1031-2025
- Recalling firm
- Boston Scientific Corporation
- Product
- AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
- Status
- Open, Classified
- Initiated
- 2024-12-20
- Posted
- 2025-01-29
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- 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.
- Quantity
- 38 units
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Lot, serial or model codes
- GTIN: 08714729904632 Lot Numbers: 33740402, 33785754, 34037422
- 510(k) numbers
- ["K181905"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28