FDA recalls Medtronic 600-series MiniMed insulin pumps
Scott Benner
Alert says Medtronic's MiniMed device could malfunction on airplanes
From the Star Tribune: Entire article can be found here
“The problem has long been known. Medtronic first notified patients about the problem in 2017.”
The U.S. Food and Drug Administration is reminding patients who use the popular 600-series MiniMed insulin pumps made by Medtronic that the devices contain an issue that could cause their buttons to get stuck while flying or other situations when air pressure changes quickly.
The FDA on Wednesday issued alerts for more than 189,000 MiniMed insulin pumps worldwide. Such pumps are used by diabetic patients who need a steady infusion of the drug insulin to break down the glucose in their blood, in addition to periodic doses (or "boluses") of insulin related to meals, exercise and other factors.
The alerts issued Wednesday are classified by the FDA as a class 2 recall, which is a medium-severity action used when a problem caused by a medical product would be temporary, or when the probability of serious adverse consequences related to the problem is considered remote.
Medtronic has issued an urgent safety notification to patients, which the FDA calls a "recall." However, FDA and Medtronic are not requesting any devices be returned to the manufacturer. The FDA uses the term "recall" to include situations where no product need be returned.
The recalls apply to MiniMed 670G, 640G, 630G, and 620G models, which have physical keypad buttons that can temporarily become "unresponsive" when atmospheric pressure goes up or down quickly around the pump, typically during takeoff and landing.
Read the entire article here
