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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- May 15, 2014
- Posted
- June 16, 2014
- Terminated
- June 25, 2015
- Recall Number
- Z-1794-2014
- Quantity
- 968 units - all models
- Firm Location
- Fremont, CA
Reason for Recall
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Distribution
Nationwide Distribution.
Lot / Code Info
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
Root Cause
Use error
Action Taken
Customers were informed of the recall via overnight letter sent on May 15, 2014.
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