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

Recall Z-2426-2018 — Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is

U.S. FDA — Device Enforcement · United States · 2018-03-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2426-2018
Date of alert: 2018-03-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Sustainability Solutions
Product category: device
Product type: Devices

Reported risk: Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

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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