Medtronic has expanded a Class I recall of remote controllers used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps over potential cybersecurity risks. The affected remote controller models are MMT-500 and MMT-503. The medtech giant has also expanded another Class I recall of the retainer rings on its 600 series insulin pumps.
Class I recalls are the most serious type of recall, according to the US Food and Drug Administration (FDA), as using the devices could cause serious injuries or death.
Medtronic’s remote controller recall affects devices distributed between August 1999 and July 2018. So far, 31,310 devices have been recalled in the US.
In a press announcement about the remote controllers recall, the FDA said the remote controllers impacted by the issue are older models that utilize previous-generation technology.
The remote controllers are being recalled over potential cybersecurity risks. This means that unauthorized persons (someone other than a patient, patient caregiver or healthcare provider) could potentially hack into the devices to record and replay wireless communication between the remote and the MiniMed insulin pump. And then, using specialized equipment, the unauthorized user could instruct the pump to either deliver more than the required amount of insulin to a patient (causing hypoglycemia), or stop delivery altogether to cause hyperglycemia, both of which could have serious consequences, including death.
However, patients who have never programmed a remote controller ID into the pump and never programmed the easy bolus option will not be impacted by the potential security breach.
The remote controllers were initially recalled in August 2018, and as of July 2018, Medtronic is not producing or distributing the controllers in question.
In February 2020, Medtronic recalled its 600 series of MiniMed insulin pumps (Model 630G and Model 670G) due to a missing or broken retainer ring. Now, the recall has also been expanded along with the recall of the remote controllers. The retainer ring helps lock the insulin cartridge in place in the pump’s reservoir compartment, and if it isn’t firmly locked in, the device could under- or over-deliver insulin.
The Medtronic recall for its 600 series affects over 460,000 devices distributed between 2015 and 2020.
Medtronic said it will “replace any MiniMed 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge,” according to a press announcement from the FDA.
With respect to the recalled remote controllers, the FDA said they are not aware of any reports of the potential cybersecurity risk associated with the remote controllers as having caused any harm to patients.
Medtronic has begun notifying people who may have bought an affected remote controller for the MiniMed 508 insulin pump or the MiniMed Paradigm family. The company has advised consumers to immediately stop using the remote controller, turn off the easy bolus feature and disconnect it from the insulin pump. After disconnecting, they should turn off the radio frequency function and delete all remote controller IDs programmed into the pump.
Users should then contact Medtronic to arrange for a return. Return options are outlined in the FDA’s press announcement about the remote controller recall.
Last month, Medtronic recalled an implant to treat brain aneurysms over its potential to break during placement, retrieval or movement. The affected devices were the Pipeline Flex Embolization Device and the Pipeline Flex Embolization Device with Shield Technology, both of which were also categorized as Class I recalls.