Biosense Webster, Inc. Recall 87440
Description: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Biosense Webster, Inc. Recall 87440 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1286-2021 |
| Event ID | 87440 |
| Event Description | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures. |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Recall Reason | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism |
| Device Classification | 20210331 |
| Device Code Info | All Lots |
| Center Classification Date | 20210322 |
| Recall Initiation Date | 20210226 |
| Recalling Firm | Biosense Webster, Inc. |
| Initial Notification | Letter |
| Similar To |