Recall Z-1271-2016 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
| Date | Mar 29, 2016 (initiated Feb 9, 2016) |
| Status | Terminated |
| Reason | Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure. |
| Root cause | Under Investigation by firm |
| Action | Medtronic sent an "Medical Device Removal" letter dated February 2016. The letter described the problem and the product involved in the recall. The Action Required was to segregate the unused affected product. Their Medtronic Representative will be contacting consignee. For questions contact your Medtronic representative, or call for further questions. (800) 707-0933 |
| Quantity | 9 (1 still unused) |
| Distribution | Internationally to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.