BEUDAMED
    FDA Recall Terminated

    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

    Recall: Z-0380-2017 · Initiated October 6, 2016

    Recall

    Recall Number
    Z-0380-2017
    Event Number
    75409
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 6, 2016
    Terminated
    December 16, 2016
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

    Reason

    The EP Catheters may be mislabeled for French size during reprocessing.

    Action

    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to [email protected] or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If you have any questions, contact Senior Director RA at 1(888)888-3433.

    Distribution

    U.S. distribution to the following; AZ, MN and MO.

    Quantity

    4 devices