Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
- 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:
- Abbott
- Reason for Recall:
- There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Product Codes/Lot Numbers:
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2110-2023
Related Recalls
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.