Medtronic Has Expanded its Insulin Pump Controller Recall Due to Cybersecurity Hazards
A news article on Healio.com reports that Medtronic has expanded its recall of its remote insulin pump controllers that are used with the company’s MiniMed Paradigm family of insulin pumps or MiniMed 508 insulin pumps because of serious cybersecurity risks. The FDA’s press release says the FDA has identified the recall as a Class I recall. Class I recalls are the most severe kind of recall as the affected devices may cause injury or death. The recall states that the recall includes all MiniMed remote controllers (model MMT-500 and MMT-503) that are used with Medtronic MiniMed 508 insulin pumps or the MiniMed Paradigm family of insulin pumps that were distributed from August 1999 until July 2018.
According to the FDA’s announcement, “The remote controllers impacted by this issue are older models that use previous-generation technology.” the FDA stated in the release. The FDA’s media release also affirmed that that as of July 2018, Medtronic is not distributing or manufacturing these remote insulin pump controllers.
Back in 2019, Medtronic recalled some of its MiniMed insulin pumps in due to cybersecurity vulnerabilities discovered in the devices. That recall was related to the wireless communication failures between Medtronic’s MiniMed insulin pumps and some other medical devices including continuous glucose monitoring systems, blood glucose meters, CareLink USB devices, and the remote controllers used with the insulin pumps. The FDA stated that a person other than the patient, health care provider, or caregiver could connect wirelessly to a MiniMed insulin pump close by and modify the pump’s settings. This issue meant that a person could over-deliver, under deliver or stop insulin delivery.
The FDA advised patients who are using the recalled insulin pumps to switch to insulin pumps which are “better equipped to protect against potential risks.”
Medtronic has also sent updated instructions to users of these devices, including instructions how to return the remote controller, and to stop using the device. Medtronic also recalled its MiniMed 600 series insulin pumps because of a broken or missing retainer ring that kept the insulin cartridge in place inside the pump’s reservoir compartment.
Consumers who have questions for Medtronic about their insulin pump recall may call Medtronic’s 24-Hour Technical Support line which is found on the company’s website, Medtronic.com.
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