# FDA recall Z-3072-2017

> **Medspira, Llc** · Class II · device recall initiated 2017-06-14.

## Product

mcompass 2-channel Balloon Catheters    The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.

## Reason for recall

Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.

## Distribution

Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom

## Key facts

- **Recall number:** Z-3072-2017
- **Recalling firm:** Medspira, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-14
- **Report date:** 2017-09-06
- **Termination date:** 2021-08-24

- **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-3072-2017

## Citation

> AI Analytics. FDA recall Z-3072-2017. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-3072-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*