AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855, 34364514, 34772813
- 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:
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Product Codes/Lot Numbers:
GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855, 34364514, 34772813
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1026-2025
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