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.
Reported: June 25, 2014 Initiated: May 15, 2014 #Z-1795-2014
Product Description
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.
Reason for Recall
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 968 units total all models
- Distribution
- Nationwide Distribution.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 968 units total all models.
Why was this product recalled? ▼
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1795-2014.
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