FDA: Certain Medtronic insulin pumps recalled due to cybersecurity risk

Jun 28, 2019 - 02:31 PM
fda-alert-recall-compounded-drugs

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.

Related News Articles

Headline
FBI reminds of potentially malicious activity by Iranian cyber actors
The FBI is reminding critical infrastructure organizations to implement mitigations from a June 2025 fact sheet on potential actions by Iranian-affiliated…
Headline
CISA report updates findings on RESURGE malware attacks
The Cybersecurity and Infrastructure Security Agency Feb. 26 released a report that updates findings from last year on RESURGE malware used to gain covert…
Headline
Agencies issue guidance on exploitation of Cisco systems by cyber actors 
U.S. and international agencies Feb. 25 released guidance on protecting Cisco Software-defined Wide-area Networking systems from exploitation by malicious…
Headline
NSA issues guidelines on zero trust architecture
The National Security Agency has released two phases of its Zero Trust Implementation Guidelines for organizations to improve their zero trust architecture.…
Headline
CISA announces town halls to gather public input on proposed cyber incident reporting requirements
The Cybersecurity and Infrastructure Security Agency announced Feb. 13 that it will host a series of virtual town hall meetings to gather public input on…
Headline
ASPR announces competition for antiviral drug development targeting certain viruses
The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies…