Home / Recalls / Medical Devices
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessor
Recalled June 25, 2014 · FDA recall Z-1799-2014 · 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; 10m 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 →