# FDA recall Z-0537-2018

> **Medtronic Neuromodulation** · Class III · device recall initiated 2017-09-21.

## 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.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-0537-2018
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-21
- **Report date:** 2018-02-14
- **Termination date:** 2020-03-20

- **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-0537-2018

## Citation

> AI Analytics. FDA recall Z-0537-2018. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0537-2018. Source: US FDA. Licensed CC0.

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