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

Recall Z-2371-2020 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only

U.S. FDA — Device Enforcement · United States · 2020-04-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2371-2020
Date of alert: 2020-04-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BIOSENSE WEBSTER
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10846835009576

Reported risk: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

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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