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U.S. Department of Health and Human Services

Class 2 Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm)

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  Class 2 Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) see related information
Date Initiated by Firm May 15, 2014
Date Posted June 16, 2014
Recall Status1 Terminated 3 on June 25, 2015
Recall Number Z-1799-2014
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; 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.
Code Information Catalog Number: PM4790N4; Material Number: M004PM47900N4; Serial numbers: 16743269, 16872007; Expiry Dates: May 11, 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 2
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 and Original Applicant = BOSTON SCIENTIFIC
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