Device 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.
Z-1798-2014
Product summary
- Event
- Event 68373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 968 units total all models
- Official record key
device-enforcement:Z-1798-2014
Official wording
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.