The U.S. Food and Drug Administration (FDA) this week issued a Class I recall — its most serious — for the Medfusion syringe pump, the agency's third major recall of the line of devices made in Oakdale.
Smiths Medical, which was based in Plymouth before California-based ICU Medical Inc. acquired it in January 2022, has struggled for years with the pumps' software vulnerability to cyber-hacking and other malfunctions.
The FDA also issued a Class I recall, for devices that could cause serious injury or death, for specific lot numbers of Smiths' Medfusion 3500 and 4000 infusion pumps in 2022.
The 4000 model, which is designed to administer fluids and medication at controlled infusion rates, is again at the center of this week's recall. The FDA said earlier software versions potentially affected the alarm system, pump and control screen among other parts and could cause the device to fail to deliver the infusion at the proper time, if at all.
The FDA recalled 50,743 devices after learning of one injury caused by the pumps. No related deaths have been reported.
Tom McCall, a spokesman for ICU Medical, said hospitals and clinics can address the problems by installing the latest Medfusion software. The company initiated the recall in December 2023.
ICU, which reported 2022 revenue of $2.3 billion and a net loss of $74.3 million, bought Smiths for $2.55 billion from London-based Smiths Group. Smiths had emerged from St. Paul-based Deltec Inc., which was incorporated in 1984.
The 2022 recall soon after the ICU purchase affected more than 118,000 Medfusion devices after eight identified software malfunctions had caused one death and injured seven people.. Smiths also recalled Medfusion pumps in August 2020, and in 2019, the FDA issued a Class I recall for approximately 600 pediatric Medfusion pumps; both recalls were related to software problems. In 2017, Smiths had confirmed the Medfusion pumps were vulnerable to hacking.
The device manufacturing plant in Oakdale has had other issues as well.
In 2021, the FDA warned Smiths that the facility was failing to comply with medical device reporting requirements. In its most recent annual financial filing, ICU said resulting corrective actions had cost $49.8 million through the end of 2022.
That filing also indicated ICU had 100,000 square feet of corporate office space in Plymouth and about 94,000 square feet of space in Oakdale for a warehouse, manufacturing and a device service center.
In August 2023, ICU Medical announced 81 layoffs and plans to close the Oakdale facility by the end of this year, though production continues there.
"As of now," McCall said, "it's still open."
