Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (bleeding/embolism) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biosense Webster, Inc. is recalling the CARTO VIZIGO Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502. The recall covers all lots of this sterile, single-use medical device, which is used to provide accessibility and maneuverability in cardiac anatomy during electrophysiological mapping and ablation procedures. The product was distributed worldwide.
The recall was initiated because there is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This defect could result in minor bleeding and/or embolism. The U.S. Food and Drug Administration has classified this as a Class II recall.
Healthcare providers and facilities that have received this product should stop using it immediately. Users should contact Biosense Webster, Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- 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 a
- Manufacturer
- Biosense Webster, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Biosense Webster, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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