# FDA recall Z-1173-2024

> **IMPULSE DYNAMICS (USA) INC** · Class II · device recall initiated 2024-01-05.

## Product

OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

## Reason for recall

OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.

## Distribution

Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.

## Key facts

- **Recall number:** Z-1173-2024
- **Recalling firm:** IMPULSE DYNAMICS (USA) INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-05
- **Report date:** 2024-02-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2024

## Citation

> AI Analytics. FDA recall Z-1173-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1173-2024. Source: US FDA. Licensed CC0.

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