Medtronic MiniMed Insulin Pump Recall Expanded To Include Half A Million Devices

Due to continued problems with dosing, Medtronic is expanding a MiniMed 600 series insulin pump recall to include nearly half a million devices, which could over or under deliver medication. A second, smaller recall impacting more than 30,000 MiniMed and Paradigm pump remote controllers is also being announced, due to cybersecurity risks.

The FDA announced the Medtronic Minimed 600 series recall expansion on October 5, indicating the agency has designated this a class I recall, the most serious recall classification. The designation means the agency believes the pumps may pose an increased risk of injury and death to patients.

The Medtronic MiniMed insulin pumps are small, computerized devices that deliver insulin to diabetic patients throughout the day, via a catheter implanted under the skin. They are wirelessly connected to both the patient’s blood glucose meter and a monitoring system to track glucose levels, as well as a remote controller that is designed to communicate with the pump and deliver a specific amount of insulin.

According to the notice, a ring that locks the insulin cartridge in place may be missing or broken in the recalled pumps. If the insulin cartridge is not locked into place firmly, the pump could draw more or less than the programmed amount of insulin to a patient.

The original Medtronic MiniMed 600 series recall was announced in February, impacting certain 630G and 670G insulin pump models, after the manufacturer acknowledged it was aware of 26,421 complaints in which the pump over or under delivered the programmed amount of insulin, resulting in 2,175 injuries and one death.

The latest expansion now includes all 600 series MiniMed pumps; affecting an estimated 463,464 units. The FDA declared a class I recall after Medtronic sent emails and phone calls to customers announcing it was replacing the retainer ring in all 600 series pumps, including those not affected by the original MiniMed recall.

Medtronic is recommending customers determine if their units have an affected retainer ring by visiting its website at https://www.medtronicdiabetes.com/retainer-ring-serial-number-look-up/ and entering the serial number of the pump.

The company recommends customers then examine the retainer ring of the pump, and to stop using it and contact Medtronic for a replacement pump if it is loose, damaged or missing, or if the reservoir does not lock into the pump. They should then follow their doctor’s recommendations and perform manual insulin injections.

If the reservoir locks in place, and the retainer ring is not missing, damaged or loose, Medtronic indicates that consumers can continue to use the pump until they receive a replacement pump. However, Medtronic warns customers to not insert the reservoir back into the pump while connected, due to the risk of causing a rapid, and possibly large, insulin bolus, which could cause an overdose.

Medtronic MiniMed Remote Controller Recall

In addition to the main recall, the FDA also announced a second recall involving MiniMed Remote Controllers used with the Medtronic MiniMed 508 insulin pump and the MiniMed Paradigm insulin pumps. This recall affects 31,310 devices with model numbers MMT-500 and MMT-503 distributed between August 1999 and July 2018.

This is also a class I recall, which was initiated due to cybersecurity risks, and also represents an expansion of an earlier recall issued in August 2018.

“Using specialized equipment, an unauthorized person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death,” the recall warns.

The FDA is unaware of any reports of patients being harmed due to this cybersecurity risk.

Medtronic MiniMed Problems

Medtronic has had a number of problems with its Minimed infusion products over the years.

In September 2017, the FDA announced the Medtronic MiniMed infusion pump recall following reports of consumers suffering from hypoglycemia caused by over delivery of insulin. The issue was related to a component of the device called a vent membrane, which can be blocked by fluid. Medtronic discontinued the use of the vent membrane component in April 2017.

In September 2014, Medtronic issued a MiniMed Paradigm insulin pump recall for more than half a million units following reports that programming errors led to patients receiving the wrong dose of insulin. At least one report of hypoglycemia was linked to the problem, which caused some users to accidentally give themselves the maximum insulin dose.

In June 2013, the company issued a MiniMed Paradigm infusion set recall because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. It was one of four recalls or urgent device notifications involving Medtronic’s insulin pumps that year alone.

In 2009, Medtronic Inc. issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect which could result in the delivery of incorrect doses of insulin and cause injury or death for diabetics.

Following that recall, a number of Medtronic infusion set lawsuits were filed on behalf of patients of suffered serious injury or death when they received too much or too little insulin.

Customers with additional questions or concerns regarding the most recent recalls are encouraged to contact Medtronic Technical Support at 877-585-0166. Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.