—#127482

Product

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.

FDA product code: OAD — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020025S036
Affected lot / code info: Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017

Why it was recalled

Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Root cause (FDA determination)

Use error

Action the firm took

Customers were informed of the recall via overnight letter sent on May 15, 2014.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47215 Lakeview Blvd, Fremont, California 94538-6530

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2014-05-15
Posted by FDA: 2014-06-16
Terminated: 2015-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.