PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: March 19, 2025 Initiated: February 7, 2025 #Z-1330-2025

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.

Reason for Recall

Catheter manufactured at the incorrect length.

Details

Recalling Firm
Cordis US Corp
Units Affected
12 units
Distribution
US: WA OUS: Japan
Location
Miami Lakes, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cordis US Corp. Units affected: 12 units.
Why was this product recalled?
Catheter manufactured at the incorrect length.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1330-2025.