IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessorie
FDA device recall Z-1796-2014 · posted 2014-06-16 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
- Action taken
- Customers were informed of the recall via overnight letter sent on May 15, 2014.
- Root cause
- Use error
- Status
- Terminated
- Product code
- OAD
- Quantity affected
- 968 units total all models
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-05-15
- Date posted
- 2014-06-16
- Date terminated
- 2015-06-25
- Location
- Fremont, CA
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