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.
Z-1330-2025
Product summary
- Firm
- Cordis US Corp
- Event
- Event 96272
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1330-2025
Official wording
Reason: Catheter manufactured at the incorrect length.
Code information: UDI: 20705032042991/ Lot Number: 18368326
Distribution pattern: US: WA OUS: Japan
Derived failure modes
-
Unknown
Catheter manufactured at the incorrect length.