Medtronic Paradigm® Quick-set® Infusion Sets Recalled Due to Potential Injuries
Jon L. Gelman is investigating cases of patients who used Medtronic Paradigm®Quick-set® infusion sets. The sets are used with MiniMed Paradigm insulin pumps. Some patients have suffered from injury or complications from the Paradigm®Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. Some of the 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.
If you or someone you know has experienced injury related to the Medtronic Quick-set® infusion sets, contact attorney Jon L. Gelman by email or call +1 973-696-7900. Our litigation has experience in litigating and filing claims for faulty medical devices.
Paradigm® Quick-Set® Infusion Sets Defect Announced
On July 10, 2009, Medtronic, Inc., announced a defect in the Paradigm® Quick-Set® Infusion Sets. The company identified a potentially high rate of failure of the system to function properly and deliver medication to the patient in an accurate manner through the pump. The Wall Street Journal reported that the defect in this system has resulted in a recall of three million of these units by Medtronic and that Medtronic had been previously warned by the US FDA about other pump type failures.
According to Medtronic, approximately 60,000 units are potentially defective. Affected models of the Paradigm®Quick-set® Infusion Set are lot numbers beginning the number “8”:
As part of the warning, Medtronic has advised patients that they 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.
“Lot 8” Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. The list of countries affected by this recall is available at www.medtronicdiabetes.com/lot8 or by contacting any Medtronic country office.
In addition, Medtronic has suspended worldwide distribution.