Recall Z-2428-2021 ยท DQO Catheter, Intravascular, Diagnostic
Cordis Corporation
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
| Date | Sep 15, 2021 (initiated Jul 21, 2021) |
| Status | Terminated |
| Reason | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement. |
| Root cause | Device Design |
| Action | The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use. |
| Quantity | 45 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992347 | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS Cordis Corp., Oct 8, 1999 |