Recall Z-1330-2025 ยท DQY Catheter, Percutaneous
Cordis US Corp
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.
| Date | Mar 13, 2025 (initiated Feb 7, 2025) |
| Status | Open, Classified |
| Reason | Catheter manufactured at the incorrect length. |
| Root cause | Employee error |
| Action | On February 7, 2025 Cordis issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. Cordis asked consignees to take the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory for any units from the affected lot in your possession. 3. Identify and quarantine any units. Check all storage and usage locations. 3) Share this letter with others in your facility who need to be made aware of this recall and with any other facility. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to C |
| Quantity | 12 units |
| Distribution | US: WA OUS: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp., Jun 13, 2002 |