Brand
Biosense Webster, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Biosense Webster, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-12FDA-DeviceClass IVARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
Due to an observed trend of neurovascular events
- 2024-03-20FDA-DeviceClass IICARTO 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 catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and c
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
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