Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
FDA device recall Z-0063-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.
- Action taken
- Medtronic has notifed sales representatives to visit Cath lab site with the letter dated August 29, 2007 and educate the user, provide the Safety Alert Letter and document delivery of the letter with the confirmation form.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 13,940 units
- Distribution
- Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.
- Date initiated
- 2007-08-29
- Date posted
- 2007-10-31
- Date terminated
- 2008-09-08
- 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 |
|---|---|---|
| MEDTRONIC EXPORT XT CATHETER (K061958) | Medtronic Vascular | 2006-09-05 |