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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biosense Webster, Inc. is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths, 8.5F (SMALL) C3, REF: D138501. The recall involves 71,473 units distributed worldwide. The product is intended to provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
The recall is due to 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 facilities and users 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 (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 71,473
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.
See all 3 products in this recall →Related recalls
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