Recall Z-1286-2021 ยท DYB Introducer, Catheter
Biosense Webster, Inc.
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.
| Date | Feb 26, 2021 |
| Status | Completed |
| 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 |
| Root cause | Device Design |
| Action | On 2/26/21, Biosense Webster sent an "Urgent: Medical Device Correction" notification to all affected consignees via UPS. In addition, to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Precaution on inserting a dilator into VIZIGO Bi-Directional Guiding Sheath: " Use best practices for inserting or retracting any device at the hemostatic valve. " Do Not remove dilator or catheter rapidly. Damage to hemostatic valve may occur. " Aspirate slowly, only from the sideport. " Slowly remove or insert the dilator or other devices. " Once the sheath |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc., Jul 25, 2017 |