FDA Device recall Z-2352-2024
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm)
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm) by Medtronic Neuromodulation, citing design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda cathet….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2352-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-10 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Reason
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
Identifiers
| code_info | a) 8780: 1) UDI/DI 00643169202122, Lot/Serial Numbers: N690838001, N690838004, N690838005, N690839001, N690839002,…a) 8780: 1) UDI/DI 00643169202122, Lot/Serial Numbers: N690838001, N690838004, N690838005, N690839001, N690839002, N690839003, N690839004, N690839005, N690839006, N690840001, N690840002, N690840003, N690840004, N690840005, N690840006, N690841001, N690841004, N690841005, N690842001, N690842003, N690842004, N690842005, N690843001, N690843003, N690843004, N690843005, N690915002, N690915003, N690915005, N690916001, N690916002, N690916003, N690916005, N690916006, N690917002, N690917003, N690918001, N690918002, N690918003, N690918004, N690918005, N690918006, N690919001, N690919002, N690919003, N690919005, N690919006, N690920001, N690920004, N690920005, N691336003, N691336004, N691336005, N691338001, N691338003, N691338004, N691338005, N691338006, N691456001, N691456002, N691456005, N691461001, N691461002, N691461004, N691461006, N691464002, N691464003, N691464006, N691468001, N691468002, N691468003, N691468005, N691468006, N691479002, N691479003, N691479004, N691479006, N691482001, N6914 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2352-2024%22
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