Source:

Press release

October 06, 2021
1 min read
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Medtronic expands recall of insulin pump controllers due to cybersecurity risks

Source:

Press release

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Medtronic expanded a recall of remote controllers used with MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks, according to an FDA press release.

The FDA identified this as a class I recall, the most serious type of recall , meaning use of these devices may cause serious injuries or death. The recall applies to all MiniMed remote controllers (model MMT-500 and MMT-503) used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps, distributed from August 1999 to July 2018.

Recall
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“The remote controllers impacted by this issue are older models that use previous-generation technology,” the FDA stated in the release. “As of July 2018, Medtronic is no longer manufacturing or distributing these remote controllers.”

“Medtronic has no confirmed reports of a remote controller being manipulated in this manner,” a Medtronic spokesperson told Healio.

As Healio previously reported, Medtronic recalled certain MiniMed insulin pumps in June 2019 due to cybersecurity vulnerabilities identified in the device. In that recall, the potential risks were related to the wireless communication between Medtronic's MiniMed insulin pumps and other devices such as blood glucose meters, continuous glucose monitoring systems, the remote controller and CareLink USB device used with the pumps. The FDA noted that someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump’s settings. This could allow a person to over deliver insulin to a patient, leading to hypoglycemia, or, to stop insulin delivery, leading to hyperglycemia or diabetic ketoacidosis.

At the time, the FDA recommended patients using the recalled models switch to pumps that are “better equipped to protect against potential risks.”

For the expanded recall, Medtronic sent updated instructions to people who use these devices, including instructions to stop using and return the remote controller.

In February 2020, Medtronic recalled its 600 series of MiniMed insulin pumps due to a missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment.

Consumers with questions about this recall can call Medtronic’s 24-Hour Technical Support line at 800-378-2292.