Abiomed, the medical device company that GOP gubernatorial hopeful Mike Minogue served as CEO of until late 2022, was the subject of two “potentially high-risk device issue” statements from the FDA last month.

The “Early Alert: Heart Pump Issue” statement from February 3rd notes the “FDA is aware that Abiomed has issued an Urgent Medical Device Correction to notify affected customers of updated use instructions for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices.”

Minogue has highlighted his tenure as Abiomed CEO during his campaign, even producing a video focused upon the success of the Danvers-based company.

In March 2018 Abiomed agreed to pay $3.1 million to resolve kickback allegations “that it violated the False Claims Act by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps,” according to a DOJ press release.

“We expect today’s settlement with Abiomed to serve as a warning to medical device manufacturers who try to improperly influence the treatment decisions of physicians,” said then United States Attorney Andrew E. Lelling, “Providing doctors with lavish meals, or meals that focus on entertainment rather than education or science, can impair a physician’s independent medical judgment – something each and every patient is entitled to.”

Minogue served as president and CEO of Abiomed from 2004 until the sale of the company to Johnson and Johnson for a reported $16.6B in late 2022. The company holds over 1400 patents, with hundreds of additional pending patents.

The Minogue campaign has raised $14,750 from Johnson and Johnson employees over twenty-three different contributions, according to OCPF records, since the North Shore Republican announced October 1, 2025.

Last week the FDA issued a separate early alert: “The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Impella Purge Cassettes and Impella RP Pump Sets be removed from where they are used or sold.”

The company has been subject to a number of FDA notices, including two recalls in 2025.

The products mentioned in the February 2026 FDA alerts were developed during Minogue’s tenure as CEO but the Impella RP Flex with SmartAssist and the Impella RP with SmartAssist were released in 2023, after Minogue’s tenure as CEO ended in late 2022.