FDA-Device2018-03-14Class II
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 informatio
Stryker Sustainability Solutions
Hazard
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Sold states
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.
Affected count
170 devices
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2018Don't want to check this manually?
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