HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1035-2025
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