Date Initiated by Firm |
May 15, 2014 |
Date Posted |
June 16, 2014 |
Recall Status1 |
Terminated 3 on June 25, 2015 |
Recall Number |
Z-1798-2014 |
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) Large 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: PM4790K2; Material Number: M004PM47900K2; Serial numbers: 16739673, 16739674, 16739675, 16739676, 16739677, 16739678, 16739679, 16739860, 16872121, 16872935 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
|