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Biosense Webster, Inc. FDA Recalls

8 recalls on file across devices, 1 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based Class IJan 5, 2025Due to an observed trend of neurovascular events	Due to an observed trend of neurovascular events	Class IDevices	Jan 5, 2025
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designedClass IIFeb 16, 2024Due to a manufacturing issue, device under process validatio	Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main man	Class IIDevices	Feb 16, 2024
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, SterileClass IIFeb 21, 2023Incorrect labeling; specifically, the product name, lot numb	Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Dir	Class IIDevices	Feb 21, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, SterileClass IIFeb 21, 2023Incorrect labeling; specifically, the product name, lot numb	Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Dir	Class IIDevices	Feb 21, 2023
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into Class IIJun 29, 2022Outside packaging for a device indicated for introducing car	Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained wa	Class IIDevices	Jun 29, 2022
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE Class IIFeb 26, 2021There is a potential for the hemostatic valve to dislodge wh	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the she	Class IIDevices	Feb 26, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILEClass IIFeb 26, 2021There is a potential for the hemostatic valve to dislodge wh	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the she	Class IIDevices	Feb 26, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE Class IIFeb 26, 2021There is a potential for the hemostatic valve to dislodge wh	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the she	Class IIDevices	Feb 26, 2021

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