Medtronic Ascenda — Class III medical device recall Z-0537-2018
Terminated recall by Medtronic Neuromodulation, reported 2018-02-14, distributed nationwide. There is a possibility that specific lots of catheters that have recently been distributed may be at risk for
| Recall number | Z-0537-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2017-09-21 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 194 units |
| UPC / GTIN / UDI-DI | 00643169202122, 00643169202139, 00643169202153, 00643169783027 |
| Model numbers | 00643169202122, 00643169202139, 00643169202153, 00643169783027, 8780, 8781, 8784, N740471001, N740471002, N740471003, N740471004, N740471005, N740471006, N740476001, N740476002, N740476004, N740476006, N740477001, N740477002, N740477003, N740477004, N740477005, N740477006, N740479003, N740479004 and 176 more |
Product
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.
Reason for recall
There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
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-0537-2018. 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.