Recall Z-1525-2015 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Biosense Webster, Inc.
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
| Date | Apr 27, 2015 (initiated Apr 17, 2015) |
| Status | Terminated |
| Reason | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | A recall letter dated 4/17/15 will be sent to customers by FedEx to inform them that Biosense Webster is recalling Webster HIS catheter, 4Pole Fixed Curve with Auto ID (Catalog No. D1085413). The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the Voluntary Recall Certification Form and the process for returning the form, are |
| Quantity | 503 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.