Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00763000233815, All Lot Numbers
- 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:
- Medtronic Vascular Galway DBA Medtronic Ireland
- Reason for Recall:
- Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Product Codes/Lot Numbers:
UDI: 00763000233815, All Lot Numbers
Distribution:
Distributed in: US, TX, WI, CA, NY, AL, MI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2039-2020
Related Recalls
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Medtronic Vascular Galway
Stylette removal difficulties on the Euphora and Solarice products.