Device product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm 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.
Z-1794-2014
Product summary
- Event
- Event 68373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 968 units - all models
- Official record key
device-enforcement:Z-1794-2014
Official wording
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information: Catalog Number: PM4500; Material Number: M004PM45000; Serial numbers: 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, 16872836. Expiry Dates: May 7, 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.