Medtronic, Inc. and FDA notified healthcare professionals and
patients of a recall of Quick-set infusion sets that are used with
MiniMed Paradigm insulin pumps because 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. 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".
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. Customers are
being asked to return any affected infusion sets to the company.
Medtronic, Inc. and FDA notified healthcare professionals and
patients of a recall of Quick-set infusion sets that are used with
MiniMed Paradigm insulin pumps because 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. 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".
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. Customers are
being asked to return any affected infusion sets to the company.