Medtronic is recalling specific lots of MiniMed infusion sets after learning of the risk of insulin overdelivery. The global, voluntary recall affects older insulin pump infusion sets that featured a vent membrane susceptible to blockage and consequently to overdelivery of insulin.
Patient field reports and a root cause analysis suggest overdelivery of insulin occurs shortly after an infusion set change if the vent membrane becomes blocked during the priming process. Medtronic thinks such blockages happen when insulin, alcohol or water comes into contact with the top of the insulin reservoir.
This is more than a hypothetical concern. Some patients suffered hypoglycemia, requiring medical intervention that may have resulted from a faulty vent membrane.
Medtronic first responded to the risk by redesigning its vent membrane to make it less likely to block up. But it has now gone a step further by pulling MiniMed products released before this April update from the market. Medtronic has shared a prepaid label so people with pre-April MiniMed products can swap their devices for the new version for free.
“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,” Francine Kaufman, M.D., CMO at Medtronic's diabetes group, said in a statement. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
Medtronic thinks the recall will have minimal impact on its business. The medtech manufacturer told investors the recall is unlikely to harm revenue growth in its second-quarter or full-year results. The cost of the recall is harder to predict as it depends on how many unused sets are returned. However, Medtronic thinks the cost of the recall is unlikely to escalate to the point it puts a dent in its second quarter or full year earnings per share.
The recall is Medtronic’s fifth of 2017. Earlier in the year the company initiated recalls related to its ventricular assist devices, implantable drug infusion pumps and StrataMR adjustable valves and shunts.