Product Wiki · Recalls · U.S. FDA — Device Enforcement

IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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. — recall Z-1797-2014

U.S. FDA — Device Enforcement · United States · 2014-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1797-2014
Date of alert
2014-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
16538009
Reported risk: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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