ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606
- 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:
- St Jude Medical Inc.
- Reason for Recall:
- Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Product Codes/Lot Numbers:
Serial Number: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2070-2019
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