The FDA has issued a Class I recall of the Medtronic MiniMed Paradigm Insulin Infusion Sets due to a safety issue that can occur if insulin or other fluids come into contact with the inside of the tubing connector.

If this occurs, it can temporarily block the vents that allow the pump to properly prime. This may result in too much or too little insulin being delivered by the device, which can lead to serious illness.

The recall affects 37 models of Medtronic’s Paradigm infusion sets.Caution to patients was issued by the FDA to not insert the infusion set if they noticed anything unusual during the priming process, such as insulin continuing to drip from the tip of the set’s cannula after priming.

Class I recalls affect products with a reasonable risk of serious adverse events or death with use. To learn more about this recall go here.

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