The problem caused an overdelivery of insulin in some cases. A design update in April 2017 corrected the problem but some patients still have lots of defective infusion sets.
Medtronic today announced that it is informing patients worldwide of a voluntary recall of certain lots of infusion sets used with its insulin pumps.
According to a statement from the FDA, the recall is related to a discontinued component in these infusion sets and does not include the insulin pumps themselves or the glucose sensors, the critical device that reads a person’s blood sugar level in tissue fluid.
The statement reads, in part, “The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.”
“Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component, which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost,” the statement continues.
The FDA statement says Medtronic also contacted international regulatory agencies.
The statement included a comment from Medtronic Diabetes Chief Medical Officer Francine Kaufman, MD, which reads in part: "Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients," she said.
For a copy of the letter on what patients should do with recalled products, see here.