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 |
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