FDAFDA · Food and drugs·Recall number Z-1799-2014
IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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.
Published June 25, 2014 · Recall initiated: May 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Nationwide Distribution.
- Lot
- Catalog Number: PM4790N4; Material Number: M004PM47900N4; Serial numbers: 16743269, 16872007; Expiry Dates: May 11, 2014 to January 13, 2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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