FDADecember 17, 2018device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

stryker sustainability solutionsstrykerstryker sustainability

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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