On June 28, the U.S. Food and Drug Administration (FDA) announced the recall of various Medtronic MiniMed insulin pump. It was discovered that they have the potential to be hacked. The recall includes the Medtronic MiniMed Paradigm and Medtronic MiniMed 508 insulin pumps.
In their press release, the FDA noted that they’d discovered that another MiniMed insulin pump could connect to one of these devices wirelessly. The FDA warned that if this were to happen, someone else besides the health care provider, caregiver or patient could gain access to and change a pump’s settings.
If these settings were changed by someone with criminal motives, a patient would potentially have their insulin dose stopped. This could result in diabetic ketoacidosis or hyperglycemia. A patient could also end up suffering from hypoglycemia after being administered more insulin than they should have been.
The FDA said that Medtronic hasn’t yet come up with a software update that would fix these devices’ security flaws. As many as 4,000 Americans are impacted by this recall.
The FDA notes that they haven’t been made aware of any patients who’ve been hurt by this cybersecurity concern. They note that the risk that patients face to is far too great not to recall the units though.
Medtronic has sent letters to affected patients warning them of the security breach. They’ve also offered them replacement pumps.
When announcing this recall, the FDA also advised all medical device manufacturers to assess their products for potential cybersecurity vulnerabilities. They also urged them to be proactive in reporting and coming up with solutions to address them.
Medtronic’s insulin pump isn’t the company’s first medical device to be recalled. A recall was issued for their telemetry systems and implantable cardiac devices back in March of this year because FDA regulators believed that they too had cybersecurity vulnerabilities.
Manufacturers and the FDA are both becoming better about identifying defective drugs and faulty medical devices early on. They don’t always catch everything before someone gets hurt. An experienced attorney can hold these manufacturers accountable for putting consumers at risk and those who have been harmed get the compensation they deserve.