Medtronic Recalls Infusion Sets
Medtronic Inc. has voluntarily recalled certain lots of its Quick-set infusion sets used with MiniMed Paradigm insulin pumps. The company said people who have infusion sets with reference numbers MMT-396, MMT-397, MMT-398, and MMT-399 and lot numbers beginning with 8 should stop using them.
The lot number is marked both on the product box label and on each infusion set package, below the reference number. More information about how to determine whether you have an affected infusion set is available at Medtronic's diabetes Web site.
An infusion set is a thin plastic tube used to deliver insulin from a pump. The user replaces it about every three days. Medtronic said it had found that about 2 percent of the lot 8 infusion sets—about 60,000 in all—may not work properly because they are blocking the insulin pump from venting air pressure as designed. That could result in the pump delivering too much or too little insulin and put the user's health at risk.
Medtronic asked customers to return any affected infusion sets to the company and said they would be replaced free of charge. Customers may call Medtronic's information line at 1-800-345-8139.
Problems with this or any other diabetes device or medication may be reported to the Food and Drug Administration's MedWatch Program or by calling 1-800-332-1088.