Recall archive / FDA device enforcement
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for i... — FDA record Z-1330-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Cordis US Corp
- Quantity
- 12 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1330-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 20705032042991/ Lot Number: 18368326 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: WA OUS: Japan
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 19, 2025
- Recall initiation date
- Feb 7, 2025
- Center classification date
- Mar 13, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.