# FDA recall Z-2352-2024

> **Medtronic Neuromodulation** · Class II · device recall initiated 2024-05-10.

## 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.

## Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq,  Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.

## Key facts

- **Recall number:** Z-2352-2024
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-10
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2352-2024

## Citation

> AI Analytics. FDA recall Z-2352-2024. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2352-2024. Source: US FDA. Licensed CC0.

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