# FDA recall Z-2098-2019

> **Alto Development Corp** · Class II · device recall initiated 2019-06-21.

## Product

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)-  Temporary Pacing Electrode as follows:  021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0)  021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0)  021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0)    Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

## Reason for recall

Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series)  to be consistent between electrode IFU and instructions for M-21 loop.

## Distribution

Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.

## Key facts

- **Recall number:** Z-2098-2019
- **Recalling firm:** Alto Development Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-21
- **Report date:** 2019-08-07
- **Termination date:** 2020-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wall Township, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2019

## Citation

> AI Analytics. FDA recall Z-2098-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2098-2019. Source: US FDA. Licensed CC0.

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