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

Recall Z-0916-2018 — Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of th

U.S. FDA — Device Enforcement · United States · 2018-01-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0916-2018
Date of alert
2018-01-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Sustainability Solutions
Product category
device
Product type
Devices
Reported risk: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
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.

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