BEUDAMED
    FDA Enforcement Class I Ongoing

    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    Recall: Z-1935-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1935-2026
    Event ID
    98682
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    April 2, 2026
    Classification Date
    May 1, 2026
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    Reason

    Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

    Code Info

    UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191

    Distribution

    US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay

    Quantity

    271