Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
- 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
- Reason for Recall:
- St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Product Codes/Lot Numbers:
Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0187-2014
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