Yet another FDA Class 1 recall for Minnesota-made infusion syringe pumps
The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale.
Smiths Medical, formerly based in Plymouth before California-based ICU Medical Inc. acquired it in January 2022, has struggled for years with the software on these pumps being vulnerable 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 of the pumps — designed to administer fluids and medication at controlled infusion rates — is again at the center of this most recent recall because of earlier software versions potentially affecting the alarm system, pump and control screen among other parts, per the FDA. These could cause the device to fail to deliver the infusion at the right time, if at all.
The FDA recalled 50,743 devices after learning of one injury the pumps caused. There have been no related deaths.
Tom McCall, a spokesman for ICU Medical, said hospitals and clinicians can address the problems by installing the latest Medfusion software. ICU initiated the recall in December 2023.
ICU — which reported 2022 revenue of $2.3 billion and a net loss of $74.3 million — purchased Smiths for $2.55 billion from the company's previous owner, London-based Smiths Group. Smiths had emerged from St. Paul-based Deltec Inc., 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 seven injuries and one death. Smiths also issued a recall for Medfusion pumps in August 2020, while the FDA Class I recall for approximately 600 pediatric Medfusion pumps happened in 2019, both 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, Smiths received a warning letter from the FDA for its Oakdale facility failing to comply with medical device reporting requirements. In its most recent annual financial filing, ICU said corrective actions to address the warning letter 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.
This past August, ICU Medical announced 81 layoffs and plans to close the Oakdale facility by the end of 2024, though it is currently producing devices there.
"As of now," McCall said, "it's still open."
