| 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 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 |
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 |
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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
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