HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272
- 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 6mmx8mm UPN: M00553520
Product Codes/Lot Numbers:
GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1032-2025
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