FDA-Device2019-01-30Class II
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
Stryker Sustainability Solutions
Hazard
Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.
Sold states
US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and Canada.
Affected count
103 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2019Don't want to check this manually?
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