Monday, July 15, 2013 9:20 PM
FDA Slaps Highest-Risk Label for Medtronic's Insulin Pump Recall
FDA has put its highest-risk label, Class I, on a recall of Medtronic's Paradigm insulin infusion pumps.
Medtronic Canada said last month that it received two reports on its Paradigm and Polyfin infusion devices, concerning the over- and under-delivery of insulin therapy.
Medtronic had informed patients, healthcare providers and pharmacies in Canada of the potential problem, to explain how to avoid it.
In an update issued July 12, FDA said that the Paradigm pumps were recalled "because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the tubing connector."
"If this occurs it can temporarily block the vents that allow the pump to properly prime," according to the FDA notice
. "This can result in too much or too little insulin being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious illness."
The federal watchdog agency asked that patients keep an eye out for anything unusual while they are priming their pumps, such as a drip from the top of the infusion set cannula. The FDA asked refrain from using the pump and that they immediately call Medtronic's 24-hour help line.
The new FDA warning did not mention the Polyfin pumps.