BEUDAMED
    FDA Recall Terminated

    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: Z-0766-2019 · Initiated December 17, 2018

    Recall

    Recall Number
    Z-0766-2019
    Event Number
    81880
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    December 17, 2018
    Terminated
    December 8, 2023
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    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

    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.

    Action

    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter and attached Recall Effectiveness Check Form to Stryker Sustainability Solutions (SSS) sales representatives and international Stryker divisions to notify affected customers beginning on 12/17/2018.The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Use of the affected product(s) should be discontinued. 1) Please check your inventory for the affected devices. Affected devices may be identified through Serial Number or Expiration Date. 2) Please complete the Urgent Medical Device Recall Effectiveness Check Form (page 5) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: [email protected] b. To your Stryker Sustainability Solutions Sales Rep c. Fax: 480-763-5345. This form must be completed and returned to Stryker even if no affected product is found. If you have any questions, contact Manager, Post-Market Surveillance, at 888-888-3433 or email: [email protected].

    Distribution

    US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and Canada.

    Quantity

    103 units