FDA recall Z-1330-2025

Cordis US Corp · Class II · device

Product

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.

Reason for recall

Catheter manufactured at the incorrect length.

Distribution

US: WA OUS: Japan

Key facts

Status: Ongoing
Initiation date: 2025-02-07
Report date: 2025-03-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2025