FDA Device recall Z-1723-2014
Medtronic Model 8780 Ascenda Intrathecal Catheter
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Medtronic Model 8780 Ascenda Intrathecal Catheter by Medtronic Neuromodulation, citing medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1723-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-02 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | CT |
Product
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.
Reason
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Identifiers
| code_info | N457062003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1723-2014%22
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