Medtronic Minimed Paradigm Insulin Infusion Set Recall
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Thamanna Hussain
Diabetic patients using the MiniMed Paradigm Insulin pump from Medtronic should be aware of the potential risk of insulin or other fluids coming in contact with the tubing connectors as it can temporarily clog the vents that allow the pump to work. The U.S. Food and Drug Administration announced the recall of Medtronic's MiniMed Paradigm Insulin Infusion Sets, stating that the product could result in diabetes patients getting too much or too little insulin. If that does occur, patients can face serious illnesses.
This alert is classified as a Class I recall, which affects 37 models of Medtronic's Paradigm infusion sets and can lead to a reasonable risk of serious adverse events. The company notified healthcare professionals, customers, and distributors warning them of safety issues. Medtronic recommends that if the tubing connector or the end of the insulin reservoir becomes wet, patients should start over with a new reservoir and infusion set.
The FDA recommends that if patients notice anything unusual during the infusion process, immediately call the HelpLine at 1-888-204-7616 for assistance.