Medtronic recalled its MiniMed Paradigm Insulin Infusion devices due to a safety issue that may result in patients experiencing hypoglycemia or hyperglycemia, which can lead to severe illness or death.
Online, July 15, 2013 (Newswire.com) - Medtronic recalled its MiniMed Paradigm Insulin Infusion devices due to a safety issue that may result in patients experiencing hypoglycemia or hyperglycemia, which can lead to severe illness or death.
MiniMed Paradigm Insulin Infusion sets are used by patients with diabetes who require administered insulin to maintain acceptable blood glucose levels. The Paradigm infusion sets are intended for use with Medtronic's Paradigm insulin infusion pumps.
The defect in this product may manifest when insulin or other fluids come in contact with the inside of the tubing connector. This can temporarily block the vents that allow the pump to properly prime, causing too much or too little insulin to be delivered to the patient.
In its recall, the Food and Drug Administration issued the following recommendation to patients treating with the device:
if you 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, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion set and immediately call the HelpLine at 1-888-204-7616 for assistance.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. A patient may complete and submit the report online at http://www.fda.gov/Safety/MedWatch/default.htm
The MiniMed Paradigm Insulin Infusion models included in this recall include those manufactured from October 2001 through June 2013, and distributed from December 2001 through June 2013. A list of all affected models may be found here: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm360618.htm?source=govdelivery.
If you or a loved one suffered from a defect in the MiniMed Paradigm Insulin Infusion devices, please contact Keefe Bartels, LLC, immediately by calling 1-877-ATTY-24-7. Attorneys at Keefe Bartels have previously represented loved ones of victims of defective Medtronic infusion sets. We are available for free legal consultations to those harmed by the use of defective medical devices during treatment.
Keefe Bartels, LLC, handles complex medical device implant litigation throughout the nation. The firm's offices are headquartered in New Jersey. For more information, please visit the firm's website at www.defectivejoints.com.