Recall Z-1723-2014 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
| Date | Jun 4, 2014 (initiated May 2, 2014) |
| Status | Terminated |
| Reason | Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | There was only one consignee affected by the recall. The consignee was contacted by phone on 5/2/14 and the information was provided verbally. General Manager & Vice President, Pain Stimulation/Targeted Drug Delivery spoke via phone with the physician managing the patient. The following information was provided: "Medtronic identified the potential for endotoxin levels exceeding USP requirements on product recently implanted (Model 8780, serial number N457062003). "There may be the potential for serious patient injury due to endotoxin within the first hours after implant. "Medtronic recommen |
| Quantity | 1 |
| Distribution | Distributed in the state of CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.