Avanos MicroCool: Failed Tests and Green Spreadsheets

In the Avanos MicroCool deferred prosecution agreement, Avanos Medical admitted selling hundreds of thousands of misbranded surgical gowns worth approximately $8,939,000 and obstructing a Food and Drug Administration inspection. Hospitals asking whether the gowns met the promised protection standard received test results manipulated by the company’s own gown expert. Agency investigators later received spreadsheets in which failed and unperformed tests had changed from red warnings to green results.

The Justice Department announced the agreement on July 8, 2021. This was a criminal misbranding case under the Federal Food, Drug, and Cosmetic Act.

Avanos began as Halyard Health in an October 2014 spin-off of its predecessor’s health care business. It sold surgical gowns directly to hospitals and other health care providers and through distributors, in the United States and abroad. It sold the gown business in 2018 and changed its name to Avanos Medical.

What the MicroCool Label Promised

AAMI Level 4 was the highest barrier-protection rating under the surgical-gown standard described in the agreement. The American National Standards Institute and the Association for the Advancement of Medical Instrumentation developed that standard. It covered gowns intended for surgery and other high-risk procedures involving patients suspected of having infectious diseases. The rating concerned protection for both the healthcare worker and the patient.

The agreement’s account of the standard explains why the sleeve seam mattered. A gown had to demonstrate resistance to blood-borne pathogens in every critical zone, the areas most likely to contact blood, body fluids or other potentially infectious material. The sleeve seam was one of those zones. Protection in the fabric could not answer for a seam that let fluid through.

A 2012 revision required more rigorous testing. MicroCool had been cleared under the earlier standard, but the later sales assurances claimed compliance with the more demanding revision. The manufacturer also had to monitor continued compliance.

Under its deferred prosecution agreement, Avanos admitted that the gowns failed viral-penetration tests at the sleeve seams during efforts to meet the revised standard. The technical leader who supplied information to sales and marketing knew about those failures. He also knew that the monthly liquid-penetration monitoring tests repeatedly failed at the same critical zone.

The Sleeve Seam the Factory Could Not Reliably Seal

Avanos’s statement of facts describes a manufacturing process that could not consistently produce properly sealed sleeve seams. The fabric was manufactured in the United States and converted into finished gowns at a plant in Honduras. Thermal impulse sealers, called bar sealers in the agreement, sealed the sleeves.

The machines were unstable. Operators could not find fixed time and temperature settings that consistently made a proper seam, so the process could not be validated at fixed settings. Plant workers instead relied on visual inspections. Improperly sealed seams could crack, develop holes or come apart.

The technical leader knew the process was failing. He had helped develop MicroCool, worked with the Honduras plant on sampling and testing, and served as an internal expert on the gown’s construction. The same employee also provided product information to marketing and reassured hospital customers. His knowledge crossed the factory, the testing program and the sales conversation.

The agreement traces a corrective-action project at Avanos’s predecessor to early 2013. The proposed solution was to replace the bar sealers with continuous band sealers that the team believed could be validated. In an internal message about the replacement, written in 2013 before the spin-off, the technical leader described its purpose plainly:

That was the company’s own expert describing work needed to make the existing product meet its claims. The replacement machines did not begin sealing MicroCool sleeve seams until mid-January 2015. The gowns kept being made and sold with that claim on the label; after the spin-off, Avanos continued until mid-January 2015.

Hospital Questions Brought Manipulated Test Results

Under the agreement, Avanos admitted that its technical leader helped prepare misleading marketing materials, presentations and customer letters, and made false assurances in hospital meetings and telephone conferences. The deception reached buyers through direct answers to their questions as well as through the label.

In November 2014, hospitals and other potential purchasers asked whether MicroCool met the protection standard in all critical zones. Some requests followed a class action alleging defective gowns. Others concerned obtaining gowns for the response to the Ebola outbreak.

The technical leader reviewed and contributed to four customer letters that claimed compliance with the revised standard. To support that claim, he inserted sleeve-seam test results he had manipulated by preselecting and pretesting the samples. The agreement says he knew the gowns had never met that standard.

A hospital saw a letter backed by results. Inside the manufacturer, the person supplying those results knew about the failed monitoring tests and the machinery that needed replacing. Hospitals were asking whether staff and patients would be protected. The assurance concealed the very information they needed.

From approximately November 1, 2014, through January 15, 2015, Avanos continued using the bar sealers to make MicroCool gowns labeled as meeting the revised protection standard.

The FDA Inspection Turned Red Failures Green

Under its deferred prosecution agreement, Avanos also admitted that a quality employee and a technical writer altered records during the Food and Drug Administration’s July 2016 for-cause inspection of the surgical gown business. The writer had been hired through a staffing agency. Investigators requested charts summarizing stability tests for MicroCool and other gowns. The company prepared Excel spreadsheets containing dozens of results.

The admitted account of the inspection distinguishes the drafts from what investigators received. Initial drafts highlighted failed tests in red and labeled them “fail” or “inconclusive.” Tests that had never been performed appeared in red as “not tested.”

The quality employee made false entries in three testing-summary spreadsheets. Red entries for failed, inconclusive or unperformed tests became green entries marked “pass” or “inconclusive,” with references to remediation reports. In the final versions, every result in the “Pass/Fail” row was green. The word “fail” had disappeared from that row in all three spreadsheets, even though many tests had failed.

The employee told the technical writer that the changes were intended to keep investigators from noticing the failures. She also directed the writer to ensure that the referenced remediation reports supplied a rationale for the failed or unperformed tests.

In one instance, the writer copied an explanation from a report about a MicroCool test failure into a report concerning a different test failure on a different gown. The writer made no effort to establish that the explanation was true for the other product and test. The false entries therefore extended beyond the summaries into a supporting report.

The inspection story reaches an insider who never worked on the sleeve seam. The original results, the spreadsheet revisions and the instructions for explaining failures each exposed a different part of the concealment. A green summary could hide a red test, and its supporting report could contain an explanation borrowed from another product.

What Changed Inside the Business

The agreement describes changes Avanos made after the conduct, including improving the sleeve-seam manufacturing process and revising the review and approval of medical device marketing materials. It also records a reorganization that put quality and regulatory departments directly under the chief executive and increased resources for compliance and quality.

Why Sample Selection Matters

Kimberly-Clark’s later agreement covered the same MicroCool gowns, with sales beginning before the October 2014 spin-off. The case concerned test samples used to avoid a new Food and Drug Administration clearance submission after a gown change. In its separate deferred prosecution agreement, announced in August 2025, Kimberly-Clark admitted that an employee directed preparation of samples that did not meet the requirements for AAMI Level 4 testing, intending to defraud and mislead and avoid a new clearance submission. That submission was intended to show the agency that the device was as safe and effective as an already legally marketed device.

Kimberly-Clark also admitted selling millions of gowns between late 2013 and late 2014 after the fraudulent testing and without the new clearance submission. The recurring issue is who prepared the samples and what the passing result was used to justify.

A whistleblower’s amended complaint against Advanced Bionics alleged that a hand-selected Neptune sound processor and manipulated test conditions produced a passing emissions score.

In Avanos’s admitted conduct, the technical leader connected the manipulated sleeve-seam results to assurances sent to hospital buyers.

What Evidence Is Needed to Prove Fraud?

For a device-specification case, we examine the connection between actual product performance, what customers were told and what the company knew. MicroCool makes those connections concrete: failed tests, a manufacturing correction, a technical expert’s customer letters, purchase records and altered inspection summaries.

A 2020 analysis in the Journal of Forensic and Investigative Accounting, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, identifies two contributions whistleblowers make: exposing information inside the business and supplementing strained government investigative resources. Here, knowing that a green result began as a failed test changes the meaning of the spreadsheet. Knowing that a customer letter used preselected samples changes the meaning of its reassurance.

The institutional purchase is another part of the picture. Hospitals and surgery centers approve products and hold purchasing records, while device authorization, coverage and payment are separate decisions. For a civil medical device whistleblower case involving government money, we connect the false representation and the company’s knowledge to government-funded purchases or provider claims.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. Our work with an insider is to establish that payment connection alongside the product evidence, with whistleblower lawyers who understand medical device manufacturing and government-payment cases.

You Know What the Test Actually Showed

If you saw failed tests become passing summaries or customer assurances outrun the product’s performance, talk with our whistleblower experts. We work beside you to build the case from your knowledge of the product and the money, bring in medical device fraud whistleblower lawyers, and stay with you throughout the case.