Cordis US Corp: Device Recall

Recall #Z-1330-2025 · 02/07/2025

Class II: Risk

Recall Details

Recall Number
Z-1330-2025
Classification
Class II
Product Type
Device
Recalling Firm
Cordis US Corp
Status
Ongoing
Date Initiated
02/07/2025
Location
Miami Lakes, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Reason for Recall

Catheter manufactured at the incorrect length.

Product Description

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Distribution Pattern

US: WA OUS: Japan

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.