The Minneapolis Star Tribune (7/12, Walsh, 335K) reported the FDA announced a Class I recall of Medtronic Inc’s Paradigm insulin pump Friday, claiming it “could result in diabetes patients dangerously getting too much – or too little – insulin.” The company issued an “urgent safety notification to doctors and other health care professionals” last month, saying 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.” A spokeswoman for the company said Friday that Medtronic has been informed about some hospitalizations that could be related to the pump, but “those cases have not been confirmed.”

Minnesota Public Radio (7/12, Moylan) explained that one of the problems with the pump “pertains to a disposable tube that connects pumps to patients’ bodies.” Medtronic says patients must “keep the inside of the tubing connector dry” or else an uneven amount of insulin will be delivered. The Class I recall is the highest FDA warning level, “because abnormal blood sugar levels for diabetics can cause serious health problems or death.”

According to MedPage Today (7/13, Petrochko), the recall affects 37 models of the Paradigm infusion sets. Medscape (7/13, Lowes) also covers the recall.