The Prometheus Group: Manufacturer Instructions to Reuse Probes Across Patients

In the Prometheus Group probe reuse settlement, the manufacturer and its president and sole owner agreed to pay $550,000 over allegations that they taught health care providers to reuse rectal probes across patients, causing false Medicare claims. The alleged cost-saving instruction was to cover the probes with a glove or condom. For someone who trains clinicians, handles device quality or works inside a practice, the case turns on a familiar conflict: what the product’s instructions said and what people were taught to do.

The Justice Department announced the joint civil settlement on March 26, 2025, resolving its lawsuit against the Dover, New Hampshire device manufacturer and its owner. The government’s complaint followed the instruction from the manufacturer into the treatment room and then onto the provider’s Medicare bill.

What Prometheus Sold and What the Labels Said

Prometheus manufactured and marketed the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System. Both were used in pelvic muscle rehabilitation, a nonsurgical treatment to reduce or eliminate symptoms of pelvic floor disorders, including urinary and fecal incontinence. Both required a pressure probe inserted into the patient’s rectum during therapy.

The company made its own rectal pressure sensor for the Pathway system. For Morpheus, it encouraged customers to use another company’s anorectal manometry catheter. Those products carried different restrictions: the Food and Drug Administration cleared the sensor for a single user and the catheter for a single use.

Single-user means one patient may use the device repeatedly. Single-use means one use, or use on one patient during one procedure. Moving either of these products from patient to patient crossed the restriction at the center of the government’s case.

The sensor’s instructions identified it as a potential biohazard. The next instruction, reproduced in the Justice Department’s complaint announcement, was direct:

The catheter packaging said, “Do not re-use.” The government alleged that the company and its owner knew these restrictions and nevertheless encouraged cross-patient reuse for years. The written instruction kept the sensor with one patient. The alleged training sent it to the next patient under a glove.

How the Reuse Instruction Became a Medicare Claim

Prometheus allegedly caused providers to submit false Medicare claims by teaching them to deliver services with improperly reused probes. The clinic sent the bill. The manufacturer allegedly supplied the instruction that made the service unsafe and ineligible for payment.

The government’s account was specific about the incentive. Covering a probe with a glove or condom and using it on another patient would reduce the overhead costs associated with the systems. That made the cost of the consumable part of the sales and training story. According to the complaint, the saving came with an unnecessary risk of serious bacterial, fungal and viral infections for Medicare patients.

The payment theory followed that risk. The government alleged that services performed under those conditions were not reasonable or necessary and therefore did not qualify for Medicare coverage. It also alleged that Prometheus made no attempt to determine whether the probes worked effectively when reused that way.

Here, the government’s allegations concerned the provider’s treatment claims and the manufacturer’s role in causing them. Taxpayers faced bills for care that, according to the complaint, exposed patients to avoidable infection risk.

Can Single-Use Devices Be Reprocessed?

Yes. FDA treats firms and hospitals that reprocess single-use devices as manufacturers, with device-specific validation requirements. In Prometheus’s case, the government alleged that the company encouraged cross-patient reuse under a glove or condom without even determining whether the probes worked effectively that way.

What Evidence Is Needed to Prove Fraud?

For a probe-reuse case, the evidence needs to connect the manufacturer’s instruction, what it knew, the treatment delivered and the claim for payment. We examine those connections with the insider who knows the product or the practice.

A review in the Journal of Forensic and Investigative Accounting, published in 2020, explains that a False Claims Act case centers on the claim for payment. Applied here, that means following the training into the service that generated the bill. A device insider may know what customers were taught. A practice insider may know how staff used the probe.

The Owner, the Clinical Trainer and the Practice Staff

The civil case against Prometheus and its owner addressed manufacturer instructions. Separate criminal cases and civil settlements addressed the people involved in clinical training and the practices where sensors were reused. Their roles show how the conduct could travel from a device business into patient care.

The Owner’s Part in the Civil Settlement

The president and sole owner was a defendant alongside Prometheus. The government alleged that both knew the product restrictions and encouraged providers to reuse the sensors and catheters across patients to reduce operating costs. The settlement resolved the claims against both together.

The complaint reached the person running the manufacturer as well as the company. Knowledge of the labeling and the decision to promote a cheaper reuse method were part of the same allegation.

The Clinical Director’s Guilty Plea

The company’s Director of Clinical Services pleaded guilty in December 2020 to causing the adulteration of a medical device. In her guilty plea, she acknowledged the government’s evidence that reusing the rectal pressure sensor on multiple patients, even with a glove covering it, created a risk of cross-contamination with viral and bacterial diseases.

The Physician and the Practices

The Justice Department’s October 2020 account of the practice cases described the criminal case against the physician who owned Urological Solutions of Michigan and Women’s Health Care Specialists, where the sensors were reused. He pleaded guilty to health care fraud and device adulteration.

The physician also agreed to a separate $610,000 civil settlement over the practices’ billing allegations, more than the manufacturer and owner’s joint settlement. This was the provider end of the story: the services, reuse and claims inside the businesses treating patients. The later manufacturer settlement addressed the alleged instruction coming from the supplier.

The Nurse Practitioner’s Separate Role

The same Justice Department account describes the nurse practitioner’s guilty plea: she admitted failing to report ongoing healthcare fraud at the practices and adulterating medical devices.

She separately paid $500,000 to resolve civil false-claim allegations, compared with the practice manager’s $150,000 civil payment. These were individual resolutions on the practice side, distinct from the joint settlement by Prometheus and its owner.

Clinical Instructions and Billing Advice Travel Together

For someone in sales, clinical services or reimbursement, the Prometheus case explains the value of knowing what customers were actually told. In the Prometheus case, the alleged instruction was simple enough to demonstrate with a glove. Its consequences extended through the patient’s treatment to the Medicare claim.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know What the Training Left Out

If you saw a reuse instruction that contradicted the device labeling, or worked in a practice that followed it, speak to one of our Whistleblower Experts about the reuse instruction you saw. We connect your knowledge of the product, training and patient care to the payment claims, and bring in medical device fraud whistleblower lawyers who understand manufacturer-caused claims. We are your partners in building and pursuing the case from that first conversation onward.