Medtronic expands its FDA insulin pump recall.
A Medtronic pump recall has been extended to include its MiniMed 600 series of insulin pumps and MiniMed 508 remote controllers, according to the Food and Drug Administration (FDA). Both recalls are considered “Class 1,” meaning that they were pulled due to the risk of “death or serious injury.” This is the highest level of the agency’s ranking system.
The MiniMed 600 series recall now includes models 630G and 670G. According to the FDA, both of these models have a clear retainer ring that can become damaged and cause incorrect dosing. Taking this model of the market will include pulling 463,464 devices in the U.S., in total. Medtronic essentially announced to the public, “All MiniMed 600 series insulin pumps featuring a clear retainer ring with model numbers 620G, 630G, 640G, and 670G are eligible for replacement as part of the recall.”
The ring works by locking the insulin cartridge into the pump’s reservoir. If this is not operating as it should, the device may deliver more or less insulin than the user needs to properly blood sugar, resulting in either hyperglycemia (blood sugar that is too high) or hypoglycemia (too low).
Medtronic first warned users of these products in November 2019, directing them to look for signs of retainer ring wear and tear. It submitted a statement, noting, “Since November 2019,” the company “has replaced nearly half of the clear retainer ring pumps in use in the U.S. – including fulfilling replacement requests associated with the initial recall for clear retainer rings which were loose, damaged, or missing.” Now, it is saying it “will replace any pump with a clear retainer ring with one that has the updated black retainer ring at no charge within the coming months, even if the clear retainer ring is not damaged.”
The latest memo instructed patients to “immediately stop using” the pump and, instead, “switch to manual injections in the interim, and request a replacement if this clear retainer ring is loose, damaged, or missing, or if the reservoir does not lock into the pump.” The statement draws extra attention to the following statement, in bold, “DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin bolus.” If the device has a clear ring, Medtronic said, but it is not dislocated, the “user should continue operating it until a replacement is available.”
The FDA clarified, “While serious injuries and deaths have occurred with the MiniMed 600 series, none have been directly linked to the clear container rings.”
The 630G pump was distributed in the four-year span from September 2016 to February 2020. The 670G was distributed in the five-year span from May 2015 to December 2020. The recall does not include other models, such as the MiniMed 530G system, 700 series, or Paradigm insulin pumps. Each of these has a different ring design.
In a separate update, the FDA announced a recall expansion of the MiniMed 500 Series Remotes, first issued in August, to specifically cover the 508 and Paradigm remote controllers, due to “cybersecurity risks.” The recall will include 31,310 devices in the U.S. The letter reads, “If you have never programmed a remote controller ID into the pump and never programmed the easy bolus option, you are not impacted by this vulnerability.”
Medtronic, however, urged customers to “stop using the remote controller, turn off the easy bolus feature, and disconnect the remote controller from the insulin pump.” Like the previous notice, there haven’t been any reports of harm from cybersecurity breaches. Because nothing has been reported, the FDA and Medtronic have issued this one more proactively.