Medtronic is recalling certain MiniMed insulin pumps due to cybersecurity concerns, the FDA warned patients and healthcare providers June 27.
The affected MiniMed pumps have cybersecurity vulnerabilities that can't be patched, according to the company.
Medtronic said that hackers could potentially connect to the devices wirelessly, allowing them to change settings and manipulate insulin delivery.
Medtronic is urging customers to speak with providers about switching to a different model. About 4,000 patients are using the affected models, according to the report.
"While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant," said Suzzane Schwarts, MD, part of the FDA's center for devices and radiological health. "The FDA urges manufacturers everywhere to remain vigilant about their medical products — to monitor and assess cybersecurity vulnerability risk and to be proactive about disclosing vulnerabilities and mitigations to address them."
Medtronic is recalling the following pumps:
- MiniMed 508 (all software versions)
- MiniMed Paradigm 511 (all software versions)
- MiniMed Paradigm 512/712 (all software versions)
- MiniMed Paradigm 515/715 (all software versions)
- MiniMed Paradigm 522/722 (all software versions)
- MiniMed Paradigm 522K/722K (all software versions)
- MiniMed Paradigm 523/723 (software version 2.4A or lower)
- MiniMed Paradigm 523K/723K (software version 2.4A or lower)
- MiniMed Paradigm 712E (all software versions)
- MiniMed Paradigm Veo 554CM/754CM (software version 2.7A or lower)
- MiniMed Paradigm Veo 554/754 (software version 2.6A or lower)