Recall Z-1287-2021— Biosense Webster, Inc.
Class II · Completed
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2021-02-26. It names one FDA 510(k) clearance: K170997. Product: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.. 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.
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-02-26
- Firm location
- Irwindale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.