Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
FDA device recall Z-0523-04 · posted 2004-02-10 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- Catheter distal tip may separate
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 20 units
- Distribution
- NC, WA
- Date initiated
- 2004-01-14
- Date posted
- 2004-02-10
- Date terminated
- 2004-11-15
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| USCI ANGIOGRAPHIC CATHETER (K932092) | C.R. Bard, Inc. | 1993-07-29 |