Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.
The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.
The affected infusion sets have a lot number starting with “8” marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The defective infusion sets do not vent air pressure properly when delivering an insulin dose.
The sets were distributed throughout the United States and to a small number of countries outside of the U.S., such as Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. There have been no reported injuries related to the insulin pump infusion set recall, but the defect has the potential to cause fatal injury.
Last month, the FDA issued a warning letter to Medtronic about Synchromed and MiniMed pump problems. The agency warned the company that it needed to fix quality control issues in its Puerto Rico plant where the products are manufactured. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.
Medtronic is offering patients replacement Quick-set infusion sets for the MiniMed Paradigm insulin pumps in exchange for the defective ones at no charge. However, product liability lawyers who are investigating potential lawsuits for Medtronic insulin pump problems caused by the recalled Quick-set infusion sets, indicate that any units from the recalled lots should be preserved for litigation purposes if a serious or fatal injury has occurred.