Just last month, Medtronic ($MDT) warned that a mechanical issue involving a part used with its Paradigm insulin pumps could lead to the delivery of too much or too little insulin. FDA officials have now upgraded the issue to a Class I recall--the agency's most serious label.
The regulator's action affects Paradigm infusion sets, which are used with Medtronic's Paradigm insulin pumps.
The FDA noted that Medtronic issued an "urgent medical device safety notification" on June 7, warning that its Paradigm insulin pump could give too much or too little insulin, if insulin or other fluids touched the inside of the system's tubing connectors. The end result: Patients can get very sick, either from hypoglycemia or hyperglycemia. It turns out that fluids can temporarily block the vents that let the pump work properly.
Medtronic produced the affected models from October 2001 through June 2013, and distributed them from December 2001 through June 2013, regulators note. The FDA is warning patients to not insert the affected infusion set and call for assistance if they notice anything unusual, such as the insulin continuing to drip from the tip of the infusion set cannula after priming is completed. Regulators are also urging health professionals and patients to report any adverse events or problems through its MedWatch system.
In April, Medtronic faced an Australian safety advisory concerning 9 models of its Paradigm insulin pumps, due to issues including loose parts and sensor graph malfunctioning.
Separately, Medtronic recently issued four warnings over its SynchroMed infusion drug delivery pumps, outlining problems that attracted FDA Class I recalls and led to 14 deaths over 17 years.
- read the FDA recall notice