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Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessorie
Recalled June 25, 2014 · FDA recall Z-1794-2014 · Boston Scientific
Hazard
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. · FDA Class II
Units
968 units - all models
Sold at
Nationwide Distribution.
Description
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →