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

Recall Z-1591-2016 — Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 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 st

U.S. FDA — Device Enforcement · United States · 2016-04-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1591-2016
Date of alert: 2016-04-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biosense Webster, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

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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