# FDA recall Z-0068-2019

> **Surge Medical Sales, LLC (DBA Surge Cardiovascular)** · Class II · device recall initiated 2018-07-18.

## Product

Retrograde Cardioplegia Cannula, Model Number RMG-0015S     The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

## Reason for recall

The device was built with the rigid insertion stylet instead of the flexible stylet.

## Distribution

US Distribution to state of:  SC.

## Key facts

- **Recall number:** Z-0068-2019
- **Recalling firm:** Surge Medical Sales, LLC (DBA Surge Cardiovascular)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2018-10-10
- **Termination date:** 2019-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2019

## Citation

> AI Analytics. FDA recall Z-0068-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0068-2019. Source: US FDA. Licensed CC0.

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