Recall Z-0467-2019 — Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
U.S. FDA — Device Enforcement · United States · 2018-08-23 · Class II
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Reported risk: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
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