Already plagued by problems with their Sprint Fidelis leads (though, enjoying unprecedented success in the litigation arena, despite causing horrific injuries to many), Medtronic is now recalling select lots of their Paradigm Quick-Set Infusion sets. Quick-Set is used with the Medtronic MiniMed Paradigm insulin pumps by diabetes patients. It is a disposable device that delivers insulin to the patient, and is then replaced after three days of use.
Two percent of these devices, around 60,000 units, may malfunction, causing delivery of too little or too much insulin. Controlling insulin levels is tricky under the best of circumstances, so the effects of these defective devices could be fatal. The recalled lot numbers begin with an ‘8.’ (i.e., 8XXXXXX), and are located on the product’s box and the individual unit.
Read the press release here. More information is available from Medtronic here.