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.
FDA Recall Z-1799-2014 · Posted 2014-06-16
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeOAD
Date Initiated2014-05-15
Date Terminated2015-06-25
Product Quantity968 units - all models
Reason for Recall
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Firm Action
Customers were informed of the recall via overnight letter sent on May 15, 2014.
Root Cause
Use error
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.