Important Safety Update for Paradigm Reservoirs
At Medtronic, making quality products that our customers can trust is our top priority. We are committed to improving our products, as well as communicating with you about potential issues when they arise.
As part of that commitment, we are voluntarily recalling certain manufacturing lots of the insulin reservoirs used with our Paradigm insulin pumps. This recall affects approximately 13% of the volume of reservoirs Medtronic manufactures in a year. We are being cautious and recalling certain reservoir lots that were manufactured between October 2012 and February 2013 that may have an increased potential for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if you have a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify you. We are being precautionary and have decided to recall all lots that have a possibility of being affected. We have now corrected this problem and implemented additional testing and inspection steps in our manufacturing process.
We are instructing all customers with reservoirs from affected lot numbers to discard these reservoirs and Medtronic will be providing replacement product to them at no additional charge.
For more information and to check if you have any lots of reservoirs that may be affected, click here http://www.medtronicdiabetes.com/support/product-updates.
We are dedicated to providing our customers with quality products and we thank you for putting your trust in us.