Device product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Z-1796-2014
Product summary
- Event
- Event 68373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 968 units total all models
- Official record key
device-enforcement:Z-1796-2014
Official wording
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information: Catalog Number: PM4500N4; Material Number: M004PM45000N40; Serial numbers: 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, 16872124. 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.