Johnson & Johnson has recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death. It also has been warned by the U.S. Food and Drug Administration due to manufacturing concerns regarding heart devices made at its Cordis unit’s San German, Puerto Rico, facility.

J&J’s Animas unit, the maker of the recalled cartridges and insulin pumps in which they are used by diabetics, said in a letter to patients that it found some of the cartridges can leak, resulting in delivery of less insulin than intended. Insufficient insulin can cause high blood sugar and a serious condition known as diabetic ketoacidosis, which can be fatal. A spokesperson for Animas says a leaking cartridge could also cause the pump to fail to sound an alarm if there were blockage in the infusion set.

We have learned that there have been reports of 22 adverse events experienced by patients. Fortunately, none involved hospitalization or death. A total of 384,180 2.0 milliliter insulin cartridges were recalled. The cartridges came from five lots shipped in the United States and one in France between November 30^th and January 4^th. A letter posted on the Animas website listed the specific U.S. recalled lot numbers. Animas says it informed physicians and the FDA about the recall.