Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths
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 involves a medical device with a risk of harm (bleeding/embolism) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Biosense Webster, Inc. is recalling the CARTO VIZIGO Bi-Directional Guiding Sheath, 8.5F (Large) C3 (REF: D138503). The recall covers all lots of the product, which is distributed worldwide. The device is used to provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
The recall is being issued 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.
Healthcare providers and facilities should stop using the affected devices and contact Biosense Webster, Inc. for further instructions on the recall.
The recalled product
- Product
- 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 ab
- 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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