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.
A Class I recall is issued on products when "there is a reasonable chance that they could cause serious health problems or death."
Amanda Sheldon, a Medtronic spokeswoman, said Friday that the company has received some reports of hospitalizations that may be related to this problem, although those cases have not been confirmed. She said she cannot confirm any deaths in connection to the problem.
Medtronic's diabetes-related products accounted for about 9 percent of the company's $16.4 billion revenue last year.
Fewer than 500,000 patients worldwide use the Paradigm pump and customers generally replace their infusion sets every two to three days. Customers could have several months' worth of supplies. Affected models were manufactured from October 2001 through June 2013 and distributed from December 2001 through June 2013. A list of affected models can be found online on the FDA's website.
Patients also can contact Medtronic's 24-hour helpline at 1-888-204-7616. In a message to patients on its website, Medtronic said there is no need to replace the infusion sets in question.
Insulin pumps have been around for about 30 years and are an alternative to injections for diabetes patients who need insulin to maintain healthy blood glucose levels. They pump tiny amounts of insulin into the body all day long. Patients can keep it in their pocket, clipped to their belt or hidden under their clothes. A tiny tube goes from the pump to a smaller tube, called the cannula, that is just beneath the patient's skin. This tubing is the infusion set.
In its message, Medtronic recommends to patients that if they notice anything unusual during the infusion set prime process — such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed — it may mean the connector vents are not working properly. If this occurs, Medtronic said to not insert the infusion set but immediately call the helpline for assistance.
"As long as liquid does not get on the inside of the tubing connector, your infusion set should work as it's supposed to," the company wrote. "We are reminding customers of the instructions for filling their reservoir, and asking them to pay particular attention to making sure the vial of insulin is held upright when removing the reservoir from the blue transfer guard. If you do see any liquid on the top of the reservoir or inside of the tubing connector, be sure to start over with a new reservoir and infusion set."
Also on Friday, Medtronic announced it is recalling certain manufacturing lots of Paradigm reservoirs that may have the potential to leak. The reservoir is the part of the pump that contains the insulin. A leak in the reservoir may result in delivery of less insulin than intended. Medtronic said it will be contacting patients and asking them to check the lot numbers on the reservoirs they have on hand, and to stop using reservoirs from the recalled lot numbers immediately.