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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-1797-2014
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) 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: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 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 total 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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