This article is more than 5 years old. Information may no longer be current.
Medtronic voluntarily recalled specific lots of infusion sets
Click Here to Manage Email Alerts
Medtronic has recalled specific lots of Quick-set infusion sets that are used with the MiniMed Paradigm insulin pump.
The recalled infusion sets may not allow the insulin pump to vent air pressure properly, which could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. Medtronic has reported problems with approximately 2% of Lot 8 Quick-set infusion sets.
The infusion sets have lot numbers that start with the number 8. The lot number can be found on the product box label and on each individual infusion set package. View an example image of the Lot 8 Quick-set infusion set labels at the Medtronic Diabetes website.
The reference numbers are:
- MMT-396
- MMT-397
- MMT-398
- MMT-399
According to the FDA, patients are encouraged to discontinue use of Lot 8 Quick-set infusion sets. Patients and health care professionals can return these infusion sets to Medtronic and the company will provide replacement Quick-set infusion sets at no additional charge.
Report product problems to the Diabetes business at Medtronic (800-345-8139) and any adverse events to the FDA’s MedWatch program.