Medtronic Voluntarily Recalls Infusion Sets Used to Deliver Insulin from an Insulin Pump to a Diabetes Patient

We reported recently about Medco's pacemaker recall. Earlier this week, the FDA announced another Medco recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps.

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.

The affected Medco infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using "Lot 8" Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website to view the labels of "Lot 8" Quick-set infusion sets.