Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1286-2021 — Biosense 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.

U.S. FDA — Device Enforcement · United States · 2021-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1286-2021
Date of alert: 2021-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biosense Webster, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10846835016260

Reported risk: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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