FDA Recalls Certain Medtronic Medical Devices Amid Discovery of Hacking Concerns
UNITED STATES – As reported online by mHealthIntelligence.com and Stripes.com, the FDA has recalled Medtronic’s MiniMed 508 and MiniMed Paradigm Series insulin pumps following concerns that the medical devices are vulnerable to hacking.
The United States Food and Drug Administration (FDA) issued a recall of Medtronic’s MiniMed 508 and MiniMed Paradigm Series insulin pumps after discovering that the digital medical devices can be remotely accessed by an unauthorized person who may have the ability to alter the amount of insulin delivered to a patient. One FDA official states that “[w]hile 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.”
The FDA’s recent safety alert and recall notice indicate that approximately 4,000 patients use Medtronic’s MiniMed 508 and MiniMed Paradigm Series insulin pumps. The FDA’s notice informs patients using the affected insulin pump that an unauthorized person could over-deliver or under-deliver insulin, which could lead to potentially fatal health consequences. As such, these patients are instructed to work with their doctors to find a more suitable and safer insulin pump. These patients are not required to return their MiniMed 508 and MiniMed Paradigm Series insulin pumps.
While remote insulin pumps are convenient for patients and doctors, the downside of advanced technology may enable a nefarious actor to change a medical device’s settings that could pose a serious risk of harm or death to patients. According to Medtronic, the medical device company does manufacture and sell other insulin pumps that are better protected from cybersecurity vulnerabilities. Patients may be instructed to consider these safer alternatives to eliminate a potentially deadly hacking risk.
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