Recall archive / FDA device enforcement
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650 — FDA record Z-1025-2025
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 15mmx10mm UPN: M00553650
- 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
- 1144 units US; 60 units (OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1025-2025
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: 08714729904595 Lot Numbers: 32891503, 32946481, 32966087, 32976911, 32986912, 32986913, 32986914, 32996152, 33004776, 33004777, 33004779, 33008425, 33527176, 33547873, 33559652, 33562171, 33568700, 33568705, 33568709, 33580106, 33686169, 33686170, 33686171, 33686172, 33996104, 33996109, 34006713, 34052770, 34052771, 34052772, 34052773, 34065575, 34065576, 34065577, 34065578, 34136366, 33008426, 33008427, 33013790, 33013791, 33038652, 33158792, 33161956, 33219664, 33219665, 33223921, 33223922, 33223925, 33233417, 33233418, 33233419, 33233460, 33233461, 33235723, 33487216, 33487218, 33489572, 33527175, 33686173, 33686174, 33765268, 33765269, 33765271, 33765272, 33765273, 33765274, 33766684, 33775698, 33813656, 33813657, 33813658, 33813659, 33825083, 33825084, 33825087, 33825091, 33873459, 33873923, 33881493, 33996102, 34136369, 34136370, 34142870, 34142871, 34144414, 34144416, 34251354, 34261613, 34261617, 34261618, 34261619, 34263374, 34271464, 34271465, 34276937, 34276938, 34277681, 34286615, 34286616, 34286617, 34286618, 34308441 |
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.