Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Lots
- 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:
- Edwards Lifesciences, LLC
- Reason for Recall:
- The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Product Codes/Lot Numbers:
All Lots
Distribution:
Distributed in: US, VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2224-2019
Related Recalls
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.