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Class 2 Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) |
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Date Initiated by Firm |
May 15, 2014 |
Date Posted |
June 16, 2014 |
Recall Status1 |
Terminated 3 on June 25, 2015 |
Recall Number |
Z-1795-2014 |
Recall Event ID |
68373 |
PMA Number |
P020025S036 |
Product Classification |
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
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Product |
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm 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: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 47215 Lakeview Blvd Fremont CA 94538-6530
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For Additional Information Contact |
Brent Hathcock 510-440-7700
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Manufacturer Reason for Recall |
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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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
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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.
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PMA Database |
PMAs with Product Code = OAD and Original Applicant = BOSTON SCIENTIFIC PMAs with Product Code = OAD and Original Applicant = Boston Scientific Corp.
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