This blog often talks about defective medical devices. Indeed, just last week, we spoke about the Medtronic Insulin Pump recall. This week, we will explore that recall in more depth.
The product that was recalled is the Medtronic MiniMed 600 series insulin pumps. In total, they have sold approximately 463,000. They claim that they already replaced or upgraded the recalled unit for their customers, though, it is unclear that why they only upgraded some of their customers, not all.
According to the U.S. Food and Drug Administration, this class I recall (the most serious classification for a recall) is because the pumps deliver incorrect insulin doses. Incorrect insulin doses can cause serious health issues, even death, to type 1 diabetics. Specifically, the device’s retainer ring, which locked the insulin cartridges in place, was defective as it was missing, broken or easily failed. This issue resulted in higher blood sugar (hyperglycemia) or low blood sugar (hypoglycemia).
The recall was initiated in November 2019 for Models 630G and 670G. However, the recall was updated this month to include all MiniMed 600 series insulin pumps, regardless of warranty status. Houston, Texas, and Southeast Texas customer generally need only contact Medtronic’s 24-hour technical support line at 877-585-0166 to initiate the replacement or upgrade.
Both severe hypo- and hyperglycemia can result in death, and serious injuries and death have already been reported. The company maintains that none of them have ben directly related to the problematic retainer rings, the FDA still asked for the recall. This means that the evidence suggests that it is more likely than not, at least, some of the injuries and deaths were as a result of the MiniMed 600 series insulin pumps.