FDA: Certain Medtronic insulin pumps recalled due to cybersecurity risk

Jun 28, 2019 - 02:31 PM
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Medtronic has recalled certain MiniMed insulin pumps due to cybersecurity risks, and will provide alternative pumps to the estimated 4,000 U.S. patients using the pumps, the Food and Drug Administration announced yesterday. The small computerized pumps deliver insulin to a patient throughout the day through a catheter implanted under the skin, and wirelessly connect to a meter and monitoring system that measure and track the patient’s blood glucose levels. FDA said someone other than a patient or care provider could connect wirelessly to the pump and change its settings or stop insulin delivery, leading to high or low blood sugar or a buildup of acids in the blood. The agency recommends health care providers review with patients who have a recalled device the recommended safety precautions while waiting for a replacement device. FDA also urges device manufacturers to monitor and assess cybersecurity vulnerability risk and “be proactive about disclosing vulnerabilities and mitigations to address them,” said Suzanne Schwartz, M.D., deputy director of the Office of Strategic Partnerships and Technology Innovation at FDA’s Center for Devices and Radiological Health.

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