LAKE CHARLES, La. (KPLC) -
The United States Food and Drug Administration issued a class 1 recall, the most serious type of recall for more than 300,000 Medtronic insulin pumps.
“When we look at a class 1 recall, that is classified by the FDA as there’s a potential, a reasonable potential that you could expect harm either reversible or irreversible to that patient, up to and possibly related to death," said Endocrinologist, Dr. Tim Gilbert.
All lots of Medtronic MiniMed Model 630G manufactured before October 2019, and all lots of Model 670G made before August 2019 are recalled.
“There is a ring that actually keeps the insulin cartridge in place, and that ring can become broken or dislodged, and if that happens the patient can receive too much or too little insulin,” Dr. Gilbert said.
One death and over 2,000 injuries are related to the recalled devices.
According to the FDA, Medtronic sent a letter to affected patients in November 2017, advising them to check that the retainer ring is not loose or damaged, and cartridges lock into place.
“We’re not encouraging patients in any way shape or form to discontinue their Medtronic insulin pump therapy," Dr. Gilbert said. "That would be catastrophic if they were not be getting insulin by some other means. And so, this patient should not discontinue therapy without talking to their health care provider that was managing that therapy.”
Gilbert advises patients to monitor their glucose levels regularly to ensure insulin doses are correct.
Patients with questions about the recall can call the 24-hour Medtronic Technical Support line at 877-585-0166.
For more information about the insulin pump recall, click HERE.