Recall archive / FDA device enforcement
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640 — FDA record Z-1024-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 20, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
- 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.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 495 units US; 2 units(OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1024-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 08714729904588 Lot Numbers: 32891042, 32900457, 32908438, 33215358, 33215359, 33216060, 33216062, 33219660, 33219662, 33219663, 33315967, 33315970, 33324398, 33500190, 33520871, 33520872, 33537659, 33538481, 33538484, 33559005, 33813654, 33813655, 33871244, 33948086, 33996038, 33996039, 34004999, 34116469, 34116470, 34251352, 34251353, 34261614, 34261615, 34261616, 34263376, 34263377, 34277689, 34277690, 34297653, 34297657, 34512952, 34526862 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide including Puerto Rico Foreign: To be provided
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 5, 2025
- Recall initiation date
- Dec 20, 2024
- Center classification date
- Jan 30, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.