Recall archive / FDA device enforcement
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550 — FDA record Z-1035-2025
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
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
- 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
- 1530 units (OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1035-2025
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: 08714729904571 Lot Numbers: 32868212, 32947950, 32998424, 32998425, 33177074, 33177075, 33177077, 33185872, 33185873, 33185874, 33185875, 33185877, 33187647, 33187648, 33195395, 33195397, 33209120, 33209135, 33209138, 33209139, 33209840, 33243859, 33257462, 33257474, 33257477, 33268719, 33278543, 33284513, 33284514, 33284517, 33293229, 33301038, 33301039, 33301341, 33315855, 33315856, 33317299, 33318093, 33527177, 33537640, 33538743, 33577557, 33688060, 33688061, 33747542, 33747543, 33749929, 33749930, 33756082, 33756083, 33765265, 33765266, 33804645, 33805203, 33805205, 33805206, 33805208, 33893271, 33902105, 33933459, 33939639, 33948084, 33986699, 33987798, 33987799, 33988020, 33988021, 33988022, 33988779, 33989320, 34015887, 34028520, 34035525, 34035526, 34035529, 34035530, 34035965, 34044970, 34044971, 34044972, 34044973, 34047717, 34047718, 34047819, 34065662, 34065663, 34065664, 34065665, 34074525, 34074528, 34083208, 34085560, 34085561, 34086663, 34093771, 34095708, 34095710, 34095711, 34116466, 34126531, 34126534, 34126535, 34128862, 34135087, 34135090, 34161836, 34161837, 34161838, 34161839, 34163750, 34163751, 34172106, 34172107, 34180838, 34181501, 34182330, 34190948, 34201919, 34232994, 34232995, 34232997, 34334695, 34334696, 34335369, 34371098, 34372194, 34375171, 34375173, 34381805, 34512950 |
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.