Recall Z-0063-2008 ยท DQA Oximeter
Medtronic, Inc.
Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
| Date | Oct 31, 2007 (initiated Aug 29, 2007) |
| Status | Terminated |
| Reason | Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 13,940 units |
| Distribution | Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061958 | MEDTRONIC EXPORT XT CATHETER Medtronic Vascular, Sep 5, 2006 |