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Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accesso
Recalled June 25, 2014 · FDA recall Z-1796-2014 · 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 total 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); Asymmetric 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 →