The U.S. Food and Drug Administration on Friday announced the recall of a Medtronic Inc. product used with the company’s Paradigm insulin pump, saying the product could result in diabetes patients dangerously getting too much — or too little — insulin.
The Class I recall involves Medtronic’s MiniMed Paradigm Insulin Infusion Sets. Last month, Medtronic sent an urgent safety notification to doctors and other health care professionals warning that if insulin or other fluids come into contact with the inside of the device’s tubing connectors, it could temporarily block the vents that allow the pump to properly prime. If that happens, the patient may receive too much or too little insulin, potentially leading to serious illness, the FDA said.
