Metronic announces recall of insulin infusion sets
Courtesy Medtronic
Medtronic, with operational headquarters in Minnesota, has announced a recall of insulin pump infusion sets.
Medtronic, an Ireland-based medical device firm with an a location in Littleton, announced Monday a recall of infusion sets with all models of the company’s insulin pumps.
The recall includes a discontinued component in infusion sets, but doesn’t include insulin pumps or glucose sensors.
Through field reports from patients and analysis, the company concluded that a component of the infusion set - the vent membrane - may be susceptible to being blocked by fluid during the process of priming and filling tubing.
According to Medtronic, this can lead to over-delivery of insulin shortly after an infusion set change, which could cause hypoglycemia.
Current infusion sets, available since April, include an updated design which the company believes reduces the risk of over delivery.
Medtronic will work with patients to ensure the recalled sets with the old component are returned and replaced with sets with the updated component at no cost.
The company has contacted the U.S. Food and Drug Administration and other regulatory agencies in other countries, Medtronic said.
For more information, visit the company’s website.
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