IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Product Codes/Lot Numbers:
Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1795-2014
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