Recall Z-1330-2025— Cordis US Corp

Name: FDA recall Z-1330-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-07

Class II · Ongoing

Class II FDA medical device recall by Cordis US Corp, initiated 2025-02-07. It names one FDA 510(k) clearance: K021593. 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: Catheter manufactured at the incorrect length..

Recalling firm: Cordis US Corp
Classification: Class II
Status: Ongoing
Initiated: 2025-02-07
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K021593 — MODIFICATION TO ENVOY AND VISTA BRITE TIPCordis Corp.·cleared 2002-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.