Years after initiating a pair of Class I recalls for various models of its MiniMed insulin pumps—one due to a faulty locking component and the other because of cybersecurity issues with a remote controller—Medtronic has expanded the safety alerts to include even more devices.
Monday, the devicemaker updated both recall notices to include all affected devices, rather than only those under warranty or those that had already been damaged, as specified in the original recalls.
The larger of the two concerns a handful of models in the 600 series of the MiniMed insulin pumps. The devices are equipped with a plastic retainer ring meant to lock the insulin reservoir into the pump. In some cases, however, that ring can become loose or damaged if the pump is dropped or bumped, resulting in the reservoir coming loose.
If the container isn’t securely locked into place when the pump is activated, it could potentially dispense either too large or too small of a dose of insulin, depending on how the loose reservoir is positioned. According to the FDA, while many serious injuries and deaths have been reported for users of the MiniMed 600 pumps, they haven’t been definitively linked to the retainer ring issue.
The original recall, initiated in November 2019, asked only those pump owners who identified a loose or broken clear plastic retainer ring on their devices to stop using the pumps. Now, however, Medtronic has expanded that request to include all devices with clear retainer rings—rather than the stronger, all-black retainer rings that replaced the faulty ones—regardless of whether the ring is broken or the pump is still under warranty.
After identifying the clear ring, the owners of those insulin pumps can contact Medtronic via an online form for a free replacement pump, discontinuing use of their current device in the meantime if the retainer ring is damaged.
The recall affects a total of 463,464 devices in the U.S., distributed between 2015 and 2020, though many of those pumps are no longer in use.
Medtronic said that it has already replaced nearly half of the pumps equipped with clear rings since it first issued the recall in 2019. Additionally, many of the affected pumps have been replaced for other reasons unrelated to the recall, such as physician recommendations or upgrades to newer models.
The other newly expanded recall on Medtronic’s slate revolves around the optional remote controllers that diabetes patients can choose to use with their MiniMed 508 or MiniMed Paradigm pumps. The controllers are designed to communicate wirelessly with an insulin pump to manage dosage delivery.
By the time of the original August 2018 recall, though, Medtronic had identified a cybersecurity risk present in remote controllers distributed between August 1999 and July 2018. With specialized equipment, an unauthorized person could potentially hack into the connection between the controller and the pump and cause the pump to either deliver too much insulin or completely stop insulin delivery.
No issues have been reported to the FDA in connection with that hacking risk, the agency said, but Medtronic has nonetheless updated the recall to include all 31,310 devices potentially affected by the issue—after the original recall only included those still covered by warranty.
Owners of the specified models of the remotes are instructed to immediately stop using them, sever the wireless connection between the remotes and their pumps and return the controllers to Medtronic.
Editor's note: This article was updated Oct. 8 to clarify that many of the affected MiniMed 600 series pumps have already been replaced since the recall began in 2019.