FDAApril 14, 2016device
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimul...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
What to do
FDA enforcement status: Terminated
Brands named
biosense websterbiosense
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVARIPULSE 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 fi...2025-01-05
- FDACARTO 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/...2024-02-16
- FDABiosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile2023-02-21
- FDABiosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile2023-02-21
- FDACARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.2022-06-29
- FDABiosense 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 ablation procedures.2021-02-26
- FDABiosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.2021-02-26
- FDABiosense 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 ablation procedures.2021-02-26
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