Medtronic Ascenda Intrathecal Catheter — Class II medical device recall Z-2352-2024
Ongoing recall by Medtronic Neuromodulation, reported 2024-07-24, distributed nationwide. Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update
| Recall number | Z-2352-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, AW, BE, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IQ, IR, IT, JO, KW, LB, LT, LU, LV, MA, MT, MX, MY, NO, NZ, OM, PA, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, TW, ZA |
| Quantity | 111,762 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00643169061132, 00643169202122, 00643169202139, 00643169202153, 00643169359154, 00643169359178, 00643169370586, 00643169783027, 00643169793972, 00643169793989, 00643169793996, 00643169794009, 00643169794016, 00643169794023, 00643169794030, 00643169794047, 00643169794054, 00643169794061, 00643169794122, 00643169794139, 00643169794146, 00643169999633, 00643169999640, 00643169999657, 00643169999664 and 30 more |
| Serial numbers | 0212546350, 0212546351, 0212546523, 0212615690, 0212615691, 0212616872, 0212616873, 0212616874, 0212616875, 0212616876, 0212616877, 0212616878, 0212616879, 0212616880, 0212617092, 0212617093, 0212634162, 0212634164, 0212634165, 0212634166, 0212634167, 0212638095, 0212638096, 0212638097, 0212642424 and 475 more |
Product
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2352-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.