Recall Z-0766-2019— Stryker Sustainability Solutions

Name: FDA recall Z-0766-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2018-12-17, terminated 2023-12-08. It names one FDA 510(k) clearance: K112292. 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.. 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: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Terminated: 2023-12-08
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

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.

Reason for recall

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.

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