Class 2 Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm)

• Date Initiated by Firm: May 15, 2014
• Date Posted: June 16, 2014
• Recall Status: Terminated on June 25, 2015
• Recall Number: Z-1794-2014
• Recall Event ID: 68373
• PMA Number: P020025S036
• Product Classification: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
• 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.
• Code Information: Catalog Number: PM4500; Material Number: M004PM45000; Serial numbers: 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, 16872836. Expiry Dates: May 7, 2014 to January 13, 2017
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 47215 Lakeview Blvd; Fremont CA 94538-6530
• For Additional Information Contact: Brent Hathcock; 510-440-7700
• Manufacturer Reason for Recall: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
• FDA Determined Cause: Use error
• Action: Customers were informed of the recall via overnight letter sent on May 15, 2014.
• Quantity in Commerce: 968 units - all models
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = OAD