Insulin pump manufacturer Medtronic has announced two recalls in recent days, involving two separate issues with various pump models: problems with pump retainer rings, and cybersecurity concerns with remote controls, according to two device recall notices from the company.
Retainer ring recall
The first recall, involving retainer rings, affects MiniMed 600 series insulin pumps with a clear retainer ring. Medtronic first identified potential problems with retainer rings in 2019, and instructed pump users to examine their pump for any signs of problems — such as the ring being loose, damaged, or missing. Now, the company is updating the previous recall notice to recommend replacement of any insulin pump with a clear retainer ring. Affected pumps will be replaced free of charge, even if there are no problems with the retainer ring and regardless of the warranty status of the pump.
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If you are currently using an insulin pump affected by this recall, you can submit a replacement request at a special web page set up by Medtronic or call the company at 1-877-585-0166. Medtronic says that replacement pumps will be available in the coming months, and that people who submit a request will be notified when their new pump is ready to ship. As is currently the case, a replacement pump will be available immediately if you experience any problems with your pump’s retainer ring.
An insulin pump’s retainer ring locks in the reservoir of insulin that the pump uses. A reservoir can be removed from a pump, as it must be when it needs refilling, and is designed to be filled using a vial of insulin. If a reservoir is not properly locked into a pump, insufficient or excessive delivery of insulin could result, according to Medtronic — potentially resulting in hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose), both of which can be dangerous and even life-threatening in their most severe forms. So far, though, no specific cases of severe injury or death have been definitively linked to a loose, damaged, or missing retainer ring on a pump affected by this recall, according to Medtronic.
The second recall, involving cybersecurity concerns, affects the MiniMed remote controller model MMT-500 or MMT-503. Medtronic first communicated these concerns to users in 2018, with instructions on how to disable the remote bolus feature when you’re not using it. This feature lets you deliver a mealtime dose of insulin using the remote control — but also potentially means that “an unauthorized individual in close proximity of an insulin pump user could potentially copy the wireless […] signals from the user’s remote controller (for example, while the user is in the process of delivering a remote bolus) and play those back later to deliver an additional bolus of insulin to the pump user,” according to Medtronic. Only users whose pumps were under warranty at the time received this notification in 2018.
Now, Medtronic has determined that the potential risks of using the remote controller — namely, that someone with hacking capabilities could give you a bolus of insulin — outweigh the benefits of the device. Anyone with a remote controller covered by the recall should immediately disconnect it if is currently being used, disable the remote bolus feature, and return the remote controller to Medtronic. Even if your pump came with this remote control, you’re not vulnerable to the danger described above unless you specifically set up the remote for use with your pump and enabled the Easy Bolus option.
The product recall page from Medtronic explains the steps you should take if you have an affected remote controller. You can also fill out an online return request form to receive packaging with a prepaid label to return your remote controller to Medtronic.
Want to learn more about insulin pumps? Read “How to Pick an Insulin Pump or CGM” and “Type 1 Diabetes Insulin Pumps: What Are Pros and Cons for Older Adults?”