According to a new recall notice published by the U.S. Food and Drug Administration, Medtronic has expanded its recall to include 463,000 insulin pumps. The recall affects Medtronic’s MiniMed 600 Series Insulin Pumps. The recall notice states that the recalled insulin pumps are being recalled because the devices could deliver an incorrect dose of insulin to the patient. The U.S. Food and Drug Administration classified the recall as a Class I recall, which is the most serious type of recall. Class I recalls involve products or devices that can cause serious injury or death.
The Medtronic’s MiniMed 600 Series Insulin Pump recall was first announced back in November 2019 and concerned two models: Medtronic’s Model 630G and Model 670G insulin pumps. The Model 630G insulin pumps were designed for patients who are 16 years old and older. These insulin pumps were sold between September 2016 and February 2020. The Medtronic Model 670G insulin pumps, which are designed for patients 7 years old and older were sold from May 2015 until December 2020.
In the company’s October 5, 2021 recall update, Medtronic stated that it would immediately start replacing any MiniMed 600 Series Insulin Pump with an updated black retainer ring at no cost. Moreover, a replacement insulin pump would be provided regardless if the clear retainer ring was not damaged.
Medtronic earlier warned customers about broken or missing clear retainer rings fitted on its MiniMed 630G and 670G insulin pumps. The retainer ring is designed to lock the insulin cartridge into the insulin pump’s reservoir compartment. When the insulin cartridge is not firmly locked firmly into place, an over delivery or under delivery of insulin could occur.
There have been serious injuries and deaths reported among users of MiniMed 600 series insulin pumps. According to Medtronic, those incidents might not have happened due to the clear retainer rings.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Did you or a loved one sustain harm due to a defective insulin pump? Parker Waichman LLP helps those who have suffered injuries or the loss of a loved one due to another’s negligence receive full monetary compensation. Trust your case with our insulin pump lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation