Author: Rudolph F.X. Migliore
FDA and Medtronic Issue Paradigm Pump Recall
On June 7, 2013, Medtronic, manufacturer of the SynchroMed II and SynchroMed EL implantable drug infusion pumps, initiated a voluntary recall of MiniMed Paradigm Insulin Infusion Sets, citing potential safety concerns related to blockages caused by insulin or other fluids coming in contact with the inside of a tubing connector in the medical device. In a letter sent three days later, the company notified users of the potential safety risk, and provided instructions to help minimize the risk that fluid would block connector vents.
Prior Recalls Related to Medtronic Infusion Pumps
This is not the first recall involving the Medtronic infusion pumps. In 2011, Medtronic issued a recall after it learned that the batteries in certain implantable infusion pumps had a tendency to develop an internal film that caused some pumps to stop working. In 2012, the FDA issued a class I recall on the SynchroMed II and SynchroMed EL infusion pumps, citing concerns that the devices were being used to dispense unapproved medications, with a potential failure rate of approximately 7%.
The Recall on MiniMed Paradigm Insulin Infusion Sets
In a letter dated June 10, 2013, Medtronic advised customers using the MiniMed Paradigm Insulin Infusion Sets of a mechanical issue that could potentially lead to the dispensing of too much or too little insulin to users. According to the letter, if insulin or other fluids come in contact with the inside of the tubing connector on the device, the insulin or fluid can temporarily block the vents in the connector that allow the pump to initially prime and take in the proper amount of insulin. When the vents become blocked, they can lead to under-delivery or over-delivery of insulin, resulting in an increased risk of hypoglycemia or hyperglycemia, both conditions that can result in loss of consciousness or even death. The June 10 letter provides illustrated instructions to help users minimize the risk of vent blockage.
In the FDA recall notice, posted on July 12, 2013, the FDA recommends that users pay particular attention when inserting the insulin infusion set in the pump. If users observe any irregularities, such as a continuing insulin drip, they are advised not to insert the infusion set, but to call the helpline at 1-888-204-7616.
Protect Your Legal Rights
If you have used a Medtronic MiniMed Paradigm Insulin Infusion Set, you may have a potential legal claim for injuries sustained. Call the law office of Rudolph F. X. Migliore, P.C. at (631)543-3663 to arrange a free consultation to discuss your legal options. You may also contact our law firm online