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 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鈥檚 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 鈥渂e proactive about disclosing vulnerabilities and mitigations to address them,鈥 Suzanne Schwartz, M.D., deputy director of the Office of Strategic Partnerships and Technology Innovation at FDA鈥檚 Center for Devices and Radiological Health.

Related News Articles

Headline
The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride鈥
Headline
The Food and Drug Administration has identified a Class I recall of Q鈥橝pel Medical 072 Aspiration System after the company submitted three device event reports鈥
Headline
The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. BD identified an increase in material fatigue鈥
Headline
The Cybersecurity and Infrastructure Security Agency April 17 released guidance to reduce risks associated with a reported breach of Oracle cloud services.鈥
Headline
The National Counterintelligence and Security Center, the FBI, and the Defense Counterintelligence and Security Center yesterday released guidance on鈥
AHA Cyber Intel
While the rate of cyberattacks on hospitals has risen dramatically, the severity of the impacts has also grown exponentially. Let鈥檚 look at the state of cyber鈥