Medtronic and the FDA have issued a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the infusion sets may not allow the insulin pump to vent air pressure properly.

The defect could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death, according to the Minneapolis-based company. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days.

Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number 8. The agency and Medtronic said that patients should discontinue, using Lot 8 Quick-set infusion sets. The lot number (i.e., 8XXXXXX) is marked on both the product box label, and on each individual infusion set package. Lot 8 Quick-set infusion sets were distributed in the U.S., and in limited quantities in a small number of countries outside of the U.S.

Medtronic said it is providing customers with replacement Quick-set infusion sets at no additional charge.