On September 12, 2017, Medtronic initiated a worldwide recall of specific lots of MiniMed infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
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 Medtronic believes reduces the risk of insulin over-delivery after an infusion set change.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Diabetes and Its Complications: Malpractice and Other Liability Issues
See the Medical Law Perspectives Blog: Infusion Pump Failures: Product Liability and Human Error