Recall Z-0523-04 ยท DQO Catheter, Intravascular, Diagnostic
Medtronic, Inc.
Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
| Date | Feb 10, 2004 (initiated Jan 14, 2004) |
| Status | Terminated |
| Reason | Catheter distal tip may separate |
| Root cause | Other |
| Action | Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital. |
| Quantity | 20 units |
| Distribution | NC, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932092 | USCI ANGIOGRAPHIC CATHETER C.R. Bard, Inc., Jul 29, 1993 |