Recall Z-1796-2014— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2014-05-15, terminated 2015-06-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-15
- Terminated
- 2015-06-25
- Firm location
- Fremont, CA, United States
Product description
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.
Reason for recall
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.