Recall Z-1525-2015— Biosense Webster, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2015-04-17, terminated 2015-12-10. FDA's recall record names no specific 510(k) clearance for this event. Product: WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413. Reason: The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-17
- Terminated
- 2015-12-10
- Firm location
- Irwindale, CA, United States
Product description
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Reason for recall
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
Data sourced from openFDA. This site is unofficial and independent of the FDA.