Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811
- 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:
- When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Product Codes/Lot Numbers:
UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1344-2022
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.