HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109
- 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 15mmx15mm UPN: M00553570
Product Codes/Lot Numbers:
GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1037-2025
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