Recall Z-0916-2018— Stryker Sustainability Solutions

Name: FDA recall Z-0916-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-02

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2018-01-02, terminated 2018-05-02. It names one FDA 510(k) clearance: K112292. 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.. Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Terminated: 2018-05-02
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K112292 — REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERStryker Sustainability Solutions·cleared 2011-10-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

Data sourced from openFDA. This site is unofficial and independent of the FDA.