Recall – Electrode catheter EEPROM error code

Company: Stryker Sustainability Solutions
Date of Enforcement Report: 1/23/2019
Class II

PRODUCT

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.

Recall Number: Z-0766-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Stryker Sustainability Solutions, Tempe, AZ on 12/17/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
103 Units

DISTRIBUTION
U.S. Nationwide and International

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