Device 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.
Z-1795-2014
Product summary
- Event
- Event 68373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 968 units total all models
- Official record key
device-enforcement:Z-1795-2014
Official wording
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.