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# DoJ Sues Prometheus Over Device Use
- URL: https://www.fdaweb.com/doj-sues-prometheus-over-device-use/
- Published: 2022-05-18T12:00:00.000Z
- Updated: 2026-09-14T17:45:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151840

The federal government is suing The Prometheus Group, a New Hampshire manufacturer of pelvic muscle therapeutic systems and related rectal probes, and its president and sole owner **Richard Poore**,for violating the False Claims Act by causing healthcare providers to bill Medicare for services in which the providers improperly re-used single-use rectal sensors and catheters on multiple patients. A department [statement](https://click.connect.hhs.gov/?qs=55311989b429a37f3113902ebafedd6feaa270696780b014f12cc7cd2dfae3f43a4c0d0f9ed65ea9562a33e3bf3e8b3938b1ed4e332dfbf0&ref=fdaweb.com) says the government alleges that the reuse of the devices on multiple patients unnecessarily exposed vulnerable Medicare beneficiaries to the risks of serious bacterial, fungal, and viral infections.

The statement says FDA cleared the Prometheus rectal pressure sensor and the anorectal manometry catheter to each be used as a single-use device. According to the complaint, the company and its owner were aware of FDA restrictions on the use of the devices but for years encouraged and instructed healthcare providers to reuse the rectal pressure sensors and anorectal manometry catheters on multiple patients, using a glove or condom to cover the probes, as a way to reduce the overhead costs associated with Prometheus’ systems.