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Stryker Sustainability Solutions recalls Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Steril
Recalled March 14, 2018 · FDA recall Z-0916-2018 · Stryker Sustainability Solutions
Hazard
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. · FDA Class II
Units
170 devices
Sold at
USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
Description
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Product
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 the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →