Recall Z-1308-2008 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.
| Date | Jul 22, 2008 (initiated Jan 9, 2008) |
| Status | Terminated |
| Reason | Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin. |
| Root cause | Packaging process control |
| Action | Consignees were notified by an Urgent Medical Device Recall letter sent in January 2008. The letter informed users that the recalling firm would contact them regarding removing the affected products from their inventory. Users were requested to return a response form indicating the number of affected product. For additional information, contact 1-800-707-0933. |
| Quantity | 18 |
| Distribution | Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.