CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.
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: FDA Class II medical device used in critical cardiac procedures where devices were distributed without completion of required process validation. No illnesses or injuries have been reported to date. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biosense Webster, Inc. is recalling the CARTO VIZIGO Bi-Directional Guiding Sheath (Model D128502). The sheath is a cardiac catheter device designed to provide accessibility and maneuverability during cardiac procedures, featuring a steerable design with a hemostasis valve and electrodes compatible with CARTO 3 Systems.
During manufacturing, devices that were still undergoing process validation were inadvertently mixed into the main manufacturing process. As a result, some distributed units may not have completed required process validation protocols.
The recall affects 853 units with lot number 60000282, distributed nationwide across the United States.
The recalled product
- Product
- CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
- Manufacturer
- Biosense Webster, Inc.
- Hazard
- manufacturing-defect
- validation-failure
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)
- Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
Distribution
Distributed nationwide across the United States.
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