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.
Reported: March 31, 2021 Initiated: February 26, 2021 #Z-1287-2021
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
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- N/A
- Distribution
- Worldwide distribution.
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biosense Webster, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1287-2021.
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